Trial Outcomes & Findings for A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1) (NCT NCT06041256)
NCT ID: NCT06041256
Last Updated: 2025-12-17
Results Overview
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Month 6
Results posted on
2025-12-17
Participant Flow
This was a multicenter, randomized, double-masked, parallel-arm, dose-ranging Phase 1/2 study evaluating safety, efficacy, and tolerability of AURN001 in participants with corneal edema due to endothelial dysfunction. Three dose levels were compared with neltependocel and Y-27632 alone to assess each component's contribution on efficacy and safety of AURN001.
A total of 97 participants were enrolled and received the study treatment.
Participant milestones
| Measure |
Y-27632 100 µM
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel 1.0 × 10^6
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
18
|
19
|
19
|
20
|
|
Overall Study
COMPLETED
|
3
|
12
|
7
|
12
|
17
|
|
Overall Study
NOT COMPLETED
|
18
|
6
|
12
|
7
|
3
|
Reasons for withdrawal
| Measure |
Y-27632 100 µM
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel 1.0 × 10^6
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
1
|
1
|
|
Overall Study
Rescue
|
17
|
6
|
9
|
6
|
2
|
Baseline Characteristics
A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Baseline characteristics by cohort
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel 1.0 × 10^6
n=18 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.3 Years
STANDARD_DEVIATION 9.59 • n=6 Participants
|
71.3 Years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
74.7 Years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
69.3 Years
STANDARD_DEVIATION 6.91 • n=122 Participants
|
71.6 Years
STANDARD_DEVIATION 8.28 • n=488 Participants
|
71.4 Years
STANDARD_DEVIATION 9.08 • n=182 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=6 Participants
|
14 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=122 Participants
|
15 Participants
n=488 Participants
|
55 Participants
n=182 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=122 Participants
|
5 Participants
n=488 Participants
|
42 Participants
n=182 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
2 Participants
n=182 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=6 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=122 Participants
|
20 Participants
n=488 Participants
|
93 Participants
n=182 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
2 Participants
n=182 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=182 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
2 Participants
n=182 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=182 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=488 Participants
|
5 Participants
n=182 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=6 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=122 Participants
|
19 Participants
n=488 Participants
|
87 Participants
n=182 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
1 Participants
n=182 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
2 Participants
n=182 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Full Analysis Set.
Best-corrected visual acuity was assessed using Early Treatment Diabetic Retinopathy Study(ETDRS) method, standard for vision testing. Standardized Sloan letter charts with 5 letters per line, decreasing by 0.1 logarithm of minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Data presented represent number of participants with available BCVA measurements at Month 6, with those who had missing data, underwent rescue surgery before Month 6, or discontinued study prior to Month 6 imputed as non-responders.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=18 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving ≥15-letter Improvement in Best-corrected Visual Acuity (BCVA) at Month 6 - Imputed Data
|
14.3 Percentage of participants
|
44.4 Percentage of participants
|
10.5 Percentage of participants
|
36.8 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 6Population: Full Analysis Set.
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=18 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Change From Baseline in BCVA at Month 6
|
-25.5 change in ETDRS letters
Standard Error 6.06
|
-5.1 change in ETDRS letters
Standard Error 6.41
|
-15.7 change in ETDRS letters
Standard Error 6.24
|
-3.0 change in ETDRS letters
Standard Error 6.25
|
10.4 change in ETDRS letters
Standard Error 6.17
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Month 6Population: Full Analysis Set.
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=18 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Change From Baseline in Central Corneal Thickness (CCT) at Month 6
|
67.5 Microns
Standard Error 20.52
|
-7.6 Microns
Standard Error 22.17
|
-13.8 Microns
Standard Error 21.68
|
-5.6 Microns
Standard Error 21.91
|
-14.2 Microns
Standard Error 21.82
|
SECONDARY outcome
Timeframe: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=17 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Week 4
|
4.8 percentage of participants
|
5.9 percentage of participants
|
10.5 percentage of participants
|
5.3 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Month 2
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Month 3
|
6.7 percentage of participants
|
35.3 percentage of participants
|
11.8 percentage of participants
|
21.1 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Month 4.5
|
0 percentage of participants
|
42.9 percentage of participants
|
14.3 percentage of participants
|
29.4 percentage of participants
|
36.8 percentage of participants
|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Month 6
|
50.0 percentage of participants
|
57.1 percentage of participants
|
16.7 percentage of participants
|
43.8 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Month 9
|
33.3 percentage of participants
|
58.3 percentage of participants
|
37.5 percentage of participants
|
38.5 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving ≥15-letter Improvement in BCVA at All Timepoints - Observed Data
Month 12
|
0 percentage of participants
|
58.3 percentage of participants
|
28.6 percentage of participants
|
66.7 percentage of participants
|
76.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Week 4, Months 2, 3, 4.5, 6, 9 and 12Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=18 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Change From Baseline in BCVA at All Other Timepoints
Month 3
|
-19.6 change in ETDRS letters
Standard Deviation 25.82
|
-8.1 change in ETDRS letters
Standard Deviation 40.76
|
-10.6 change in ETDRS letters
Standard Deviation 22.64
|
-9.2 change in ETDRS letters
Standard Deviation 27.96
|
0.2 change in ETDRS letters
Standard Deviation 21.73
|
|
Change From Baseline in BCVA at All Other Timepoints
Month 9
|
-21.4 change in ETDRS letters
Standard Deviation 28.15
|
-5.5 change in ETDRS letters
Standard Deviation 41.19
|
-13.1 change in ETDRS letters
Standard Deviation 26.36
|
-3.8 change in ETDRS letters
Standard Deviation 28.54
|
8.2 change in ETDRS letters
Standard Deviation 18.98
|
|
Change From Baseline in BCVA at All Other Timepoints
Month 12
|
-21.5 change in ETDRS letters
Standard Deviation 28.00
|
-1.2 change in ETDRS letters
Standard Deviation 40.29
|
-14.3 change in ETDRS letters
Standard Deviation 26.16
|
-1.6 change in ETDRS letters
Standard Deviation 30.30
|
8.8 change in ETDRS letters
Standard Deviation 21.46
|
|
Change From Baseline in BCVA at All Other Timepoints
Week 4
|
-28.7 change in ETDRS letters
Standard Deviation 24.57
|
-24.6 change in ETDRS letters
Standard Deviation 33.16
|
-27.8 change in ETDRS letters
Standard Deviation 29.64
|
-26.9 change in ETDRS letters
Standard Deviation 25.04
|
-16.9 change in ETDRS letters
Standard Deviation 27.14
|
|
Change From Baseline in BCVA at All Other Timepoints
Month 2
|
-17.2 change in ETDRS letters
Standard Deviation 21.69
|
-20.5 change in ETDRS letters
Standard Deviation 37.31
|
-26.6 change in ETDRS letters
Standard Deviation 29.37
|
-24.3 change in ETDRS letters
Standard Deviation 27.63
|
-12.1 change in ETDRS letters
Standard Deviation 28.37
|
|
Change From Baseline in BCVA at All Other Timepoints
Month 4.5
|
-21.2 change in ETDRS letters
Standard Deviation 26.51
|
-8.9 change in ETDRS letters
Standard Deviation 39.80
|
-11.6 change in ETDRS letters
Standard Deviation 26.97
|
-4.1 change in ETDRS letters
Standard Deviation 28.07
|
5.4 change in ETDRS letters
Standard Deviation 19.90
|
|
Change From Baseline in BCVA at All Other Timepoints
Month 6
|
-21.2 change in ETDRS letters
Standard Deviation 28.63
|
-5.6 change in ETDRS letters
Standard Deviation 40.48
|
-15.2 change in ETDRS letters
Standard Deviation 25.26
|
-3.9 change in ETDRS letters
Standard Deviation 28.30
|
6.8 change in ETDRS letters
Standard Deviation 18.67
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 1 and 4, Months 2, 3, 4.5, 6, 9, and 12Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
Central corneal thickness was measured by pachymetry which is an essential anatomical marker for detecting the presence or absence of edema and serves as a supportive indicator of treatment efficacy. Baseline was defined as the last measurement prior to the study drug injection on Day 1. Change from baseline values was calculated as follow-up visit minus baseline visit.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=18 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Change From Baseline in CCT at All Other Timepoints
Week 1
|
87.4 Microns
Standard Deviation 89.76
|
116.9 Microns
Standard Deviation 134.59
|
93.4 Microns
Standard Deviation 155.81
|
69.4 Microns
Standard Deviation 86.47
|
117.0 Microns
Standard Deviation 138.71
|
|
Change From Baseline in CCT at All Other Timepoints
Week 4
|
97.5 Microns
Standard Deviation 117.81
|
77.3 Microns
Standard Deviation 102.40
|
35.1 Microns
Standard Deviation 126.58
|
40.7 Microns
Standard Deviation 57.74
|
66.0 Microns
Standard Deviation 78.97
|
|
Change From Baseline in CCT at All Other Timepoints
Month 2
|
63.7 Microns
Standard Deviation 61.40
|
64.4 Microns
Standard Deviation 100.38
|
47.9 Microns
Standard Deviation 45.15
|
2.6 Microns
Standard Deviation 45.88
|
36.9 Microns
Standard Deviation 72.53
|
|
Change From Baseline in CCT at All Other Timepoints
Month 3
|
60.8 Microns
Standard Deviation 115.35
|
-4.6 Microns
Standard Deviation 114.97
|
-16.1 Microns
Standard Deviation 94.48
|
-1.6 Microns
Standard Deviation 76.72
|
20.8 Microns
Standard Deviation 68.96
|
|
Change From Baseline in CCT at All Other Timepoints
Month 4.5
|
66.9 Microns
Standard Deviation 117.55
|
6.3 Microns
Standard Deviation 113.65
|
-25.0 Microns
Standard Deviation 110.49
|
-11.8 Microns
Standard Deviation 76.22
|
6.8 Microns
Standard Deviation 65.26
|
|
Change From Baseline in CCT at All Other Timepoints
Month 6
|
65.7 Microns
Standard Deviation 116.75
|
-5.7 Microns
Standard Deviation 112.03
|
-20.2 Microns
Standard Deviation 110.13
|
-16.7 Microns
Standard Deviation 66.35
|
2.6 Microns
Standard Deviation 70.27
|
|
Change From Baseline in CCT at All Other Timepoints
Month 9
|
64.8 Microns
Standard Deviation 122.48
|
-15.5 Microns
Standard Deviation 112.88
|
-21.0 Microns
Standard Deviation 114.96
|
-37.3 Microns
Standard Deviation 74.17
|
-21.7 Microns
Standard Deviation 50.56
|
|
Change From Baseline in CCT at All Other Timepoints
Month 12
|
63.0 Microns
Standard Deviation 114.77
|
-22.4 Microns
Standard Deviation 107.81
|
-19.1 Microns
Standard Deviation 113.35
|
-31.8 Microns
Standard Deviation 68.25
|
-7.6 Microns
Standard Deviation 89.14
|
SECONDARY outcome
Timeframe: At Week 4 and at Months 2, 3, 4.5, 6, 9 and 12Population: Full Analysis Set. Only those participants with data available at specified time points has been presented.
Best-corrected visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) method, the standard for vision testing. Standardized Sloan letter charts with five letters per line, decreasing by 0.1 logarithm of the minimum angle of resolution (LogMAR) per line, were used at 4 meters (or 1 meter if ≤19 letters were read, with +0.75 spherical power added). Each correct letter equaled one point (0.02 LogMAR), with 85 letters (0.0 LogMAR) corresponding to 20/20 Snellen, 70 letters (+0.3) to 20/40, and 35 letters (+1.0) to 20/200. A gain of ≥15 letters (0.3 LogMAR, 3 lines) was clinically meaningful. Data from the study eye only were included in the analysis. Participants read letters aloud, guessing encouraged, and all responses recorded for accuracy. The data presented reflect only participants with non-missing BCVA at each corresponding visit.
Outcome measures
| Measure |
Y-27632 100 µM
n=21 Participants
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel (1.0 × 10^6)
n=17 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 Participants
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 Participants
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Week 4
|
4.8 percentage of participants
|
11.8 percentage of participants
|
15.8 percentage of participants
|
5.3 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Month 2
|
0 percentage of participants
|
16.7 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Month 3
|
6.7 percentage of participants
|
47.1 percentage of participants
|
11.8 percentage of participants
|
31.6 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Month 4.5
|
16.7 percentage of participants
|
50.0 percentage of participants
|
21.4 percentage of participants
|
35.3 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Month 6
|
50.0 percentage of participants
|
57.1 percentage of participants
|
16.7 percentage of participants
|
43.8 percentage of participants
|
57.9 percentage of participants
|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Month 9
|
33.3 percentage of participants
|
83.3 percentage of participants
|
37.5 percentage of participants
|
53.8 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants Achieving ≥10-letter Improvement in BCVA at All Timepoints - Observed Data
Month 12
|
33.3 percentage of participants
|
83.3 percentage of participants
|
42.9 percentage of participants
|
66.7 percentage of participants
|
82.4 percentage of participants
|
Adverse Events
Y-27632 100 µM
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Neltependocel 1.0 × 10^6
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Y-27632 100 µM
n=21 participants at risk
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel 1.0 × 10^6
n=18 participants at risk
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 participants at risk
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 participants at risk
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 participants at risk
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
4.8%
1/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
Other adverse events
| Measure |
Y-27632 100 µM
n=21 participants at risk
Participants received a single intracameral injection of Y-27632 (100 Micromolar \[μM\]) under local anesthesia.
|
Neltependocel 1.0 × 10^6
n=18 participants at risk
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells under local anesthesia.
|
AURN001 (2.5 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 participants at risk
Participants received a single intracameral injection of neltependocel 2.5 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (5.0 × 10^5 Neltependocel + Y-27632 100 µM)
n=19 participants at risk
Participants received a single intracameral injection of neltependocel 5.0 × 10\^5 cells administered with Y-27632 100 μM under local anesthesia.
|
AURN001 (1.0 × 10^6 Neltependocel + Y-27632 100 µM)
n=20 participants at risk
Participants received a single intracameral injection of neltependocel 1.0 × 10\^6 cells administered with Y-27632 100 μM under local anesthesia.
|
|---|---|---|---|---|---|
|
Eye disorders
Ocular hypertension
|
14.3%
3/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
11.1%
2/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
15.8%
3/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.5%
2/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Conjunctival haemorrhage
|
9.5%
2/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.0%
2/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Iris adhesions
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Eye pain
|
4.8%
1/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.5%
2/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.0%
2/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Punctate keratitis
|
4.8%
1/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Detached Descemet's membrane
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Eye irritation
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Iridocele
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Keratitis
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Chalazion
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
11.1%
2/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.5%
2/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
15.8%
3/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
15.8%
3/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Infections and infestations
COVID-19
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.5%
2/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
11.1%
2/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.6%
1/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Macular oedema
|
4.8%
1/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Corneal degeneration
|
4.8%
1/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.5%
2/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
10.0%
2/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Infections and infestations
Viral infection
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.0%
1/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/21 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/18 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
5.3%
1/19 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
0.00%
0/20 • From first dose (Day 1) through Month 12
Treatment emergent adverse events (TEAEs) and serious TEAEs were collected from Safety Analysis Set which comprised of all eligible participants who received any amount of study drug during intracameral injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER