Trial Outcomes & Findings for Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma (NCT NCT02371746)
NCT ID: NCT02371746
Last Updated: 2019-10-17
Results Overview
Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only.
COMPLETED
PHASE2
41 participants
Baseline and Day 25
2019-10-17
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Group 1
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 2
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 3
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 4
2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
|
Cohort 2
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
|
Cohort 3 - Group 1
1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
|
Cohort 3 - Group 2
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
2
|
2
|
5
|
6
|
9
|
|
Overall Study
COMPLETED
|
7
|
10
|
2
|
2
|
5
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 - Group 1
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 2
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 3
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 4
2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
|
Cohort 2
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
|
Cohort 3 - Group 1
1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
|
Cohort 3 - Group 2
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Consent withdrawn
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
Baseline characteristics by cohort
| Measure |
Cohort 1 - Group 1
n=7 Participants
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 2
n=10 Participants
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 3
n=2 Participants
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 4
n=2 Participants
2 ENV515-3 implants (85.0 μg travoprost) in Study Eye for 28 days
|
Cohort 2
n=5 Participants
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
|
Cohort 3 - Group 1
n=6 Participants
1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
|
Cohort 3 - Group 2
n=9 Participants
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
13 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=7 Participants
|
9 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
28 Participants
n=41 Participants
|
|
Age, Continuous
Cohort 1
|
74.32 Years
STANDARD_DEVIATION 4.729 • n=7 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
71.99 Years
STANDARD_DEVIATION 4.213 • n=10 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
71.29 Years
STANDARD_DEVIATION 7.128 • n=2 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
62.46 Years
STANDARD_DEVIATION 8.188 • n=2 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
—
|
—
|
—
|
71.79 Years
STANDARD_DEVIATION 5.619 • n=21 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
|
Age, Continuous
Cohorts 2 and 3
|
—
|
—
|
—
|
—
|
57.412 Years
STANDARD_DEVIATION 11.4833 • n=5 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
59.472 Years
STANDARD_DEVIATION 7.2299 • n=6 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
64.462 Years
STANDARD_DEVIATION 10.4534 • n=9 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
61.203 Years
STANDARD_DEVIATION 9.8634 • n=20 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
|
Sex: Female, Male
Female
|
5 Participants
n=7 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
24 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=7 Participants
|
7 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
17 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=7 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
37 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=7 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
35 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=7 Participants
|
10 Participants
n=10 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
41 Participants
n=41 Participants
|
|
Intraocular Pressure (mm Hg)
Cohort 1
|
24.57 mm Hg
STANDARD_DEVIATION 2.370 • n=7 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
24.12 mm Hg
STANDARD_DEVIATION 2.277 • n=10 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
24.83 mm Hg
STANDARD_DEVIATION 3.064 • n=2 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
26.67 mm Hg
STANDARD_DEVIATION 1.414 • n=2 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
—
|
—
|
—
|
24.58 mm Hg
STANDARD_DEVIATION 2.267 • n=21 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
|
Intraocular Pressure (mm Hg)
Cohorts 2 and 3
|
—
|
—
|
—
|
—
|
26.2 mm Hg
STANDARD_DEVIATION 2.39 • n=5 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
28.2 mm Hg
STANDARD_DEVIATION 2.99 • n=6 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
25.2 mm Hg
STANDARD_DEVIATION 1.56 • n=9 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
26.4 mm Hg
STANDARD_DEVIATION 2.50 • n=20 Participants • Cohort 1 was analyzed separately from Cohorts 2 and 3 due to the Cohort 1 database being locked prior to the completion of Cohorts 2 and 3.
|
PRIMARY outcome
Timeframe: Baseline and Day 25Population: Safety Population
Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only.
Outcome measures
| Measure |
Cohort 1 - Group 1
n=7 Participants
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 2
n=10 Participants
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 3
n=2 Participants
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 4
n=2 Participants
2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
|
Cohort 2
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
|
Cohort 3 - Group 1
1 ENV515-3-2 implant (28.2 μg travoprost) in Study Eye for for up to 24 months
|
Cohort 3 - Group 2
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
|
|---|---|---|---|---|---|---|---|
|
Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
|
-5.10 mm Hg
Standard Deviation 1.707
|
-6.65 mm Hg
Standard Deviation 2.076
|
-3.17 mm Hg
Standard Deviation 1.179
|
-5.67 mm Hg
Standard Deviation 0.000
|
—
|
—
|
—
|
Adverse Events
Cohort 1 - Group 1
Cohort 1 - Group 2
Cohort 2 - Group 3
Cohort 1 - Group 4
Cohort 2
Cohort 3 - Group 1
Cohort 3 - Group 2
Serious adverse events
| Measure |
Cohort 1 - Group 1
n=7 participants at risk
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 2
n=10 participants at risk
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
|
Cohort 2 - Group 3
n=2 participants at risk
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 4
n=2 participants at risk
2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
|
Cohort 2
n=5 participants at risk
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
|
Cohort 3 - Group 1
n=6 participants at risk
1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
|
Cohort 3 - Group 2
n=9 participants at risk
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Corneal edema
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Number of events 1 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Corneal endothelial cell loss
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Number of events 1 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Number of events 1 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of the right nipple
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Number of events 1 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Number of events 1 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Number of events 1 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
Other adverse events
| Measure |
Cohort 1 - Group 1
n=7 participants at risk
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 2
n=10 participants at risk
3 ENV515-3 implants (42.3 μg travoprost) in Study Eye for 28 days
|
Cohort 2 - Group 3
n=2 participants at risk
1 ENV515-1 implant (42.5 μg travoprost) in Study Eye for 28 days
|
Cohort 1 - Group 4
n=2 participants at risk
2 ENV515-1 implants (85.0 μg travoprost) in Study Eye for 28 days
|
Cohort 2
n=5 participants at risk
2 ENV515-3 implants (28.2 μg travoprost) in Study Eye for up to 21 months
|
Cohort 3 - Group 1
n=6 participants at risk
1 ENV515-3-2 implant (26.1 μg travoprost) in Study Eye for up to 24 months
|
Cohort 3 - Group 2
n=9 participants at risk
2 ENV515-3-2 implants (52.2 μg travoprost) in Study Eye for up to 24 months
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Anterior chamber cell
|
14.3%
1/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
2/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Anterior chamber flare
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Anterior chamber inflammation
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Blepharitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Cataract
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
3/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Chalazion
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
2/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Conjunctival haemorrhage
|
14.3%
1/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
30.0%
3/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Conjunctival hyperaemia
|
14.3%
1/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
30.0%
3/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Corneal edema
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Corneal endothelial cell loss
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
40.0%
2/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
2/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
44.4%
4/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Corneal epithelial microcysts
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Corneal thickening
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eye allergy
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eye irritation
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eye pain
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eye pruritis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Foreign body sensation in eyes
|
14.3%
1/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
30.0%
3/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
100.0%
2/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
80.0%
4/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
3/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Iris adhesions
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Iris disorder
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Iritis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
2/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
3/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
44.4%
4/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Keratitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
30.0%
3/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Narrow anterior chamber angle
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Ocular hyperaemia
|
57.1%
4/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
30.0%
3/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
100.0%
2/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
80.0%
4/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
66.7%
4/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
44.4%
4/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Optic disc haemorrhage
|
14.3%
1/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Photophobia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
2/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
3/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Photopsia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
2/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Punctate keratitis
|
42.9%
3/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
100.0%
2/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
40.0%
2/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Recession of chamber angle of eye
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Trichiasis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
40.0%
2/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Gastrointestinal disorders
Large intestinal polyp
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
General disorders
Chest pain
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
General disorders
Instillation site pain
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Cystitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
2/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
40.0%
2/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Upper respiratory track infection
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
14.3%
1/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
50.0%
1/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
3/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
10.0%
1/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
3/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
20.0%
1/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
40.0%
2/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Vascular disorders
Hyperemia
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
16.7%
1/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
22.2%
2/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
40.0%
2/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
33.3%
2/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/10 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/2 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/5 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
0.00%
0/6 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
11.1%
1/9 • Cohort 1 - Adverse Events (AEs) were collected for up to 49 days post-treatment. Cohort 2 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 21 months (+/- 7 days) for Extension 2 post-treatment. Cohort 3 - AEs were collected for up to 12 months (+/- 7 days), 18 months (+/- 7 days) for Extension 1, and 24 months (+/- 7 days) for Extension 2 post-treatment.
In addition, the term Adverse Event of Special Interest (AESI) was used and defined to include any corneal events including corneal edema detected via slit lamp or pachymetry, corneal opacity, and any suspected changes in corneal endothelial cell counts determined by the central reading center of 30% or greater change from baseline (V2) as determined via specular microscopy. Systematic assessment included AE queries at each patient visit.
|
Additional Information
Kristin Blackwell, Consultant, Regulatory Affairs & Quality Assurance
Envisia Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place