Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of EXN407 (NCT NCT04565756)
NCT ID: NCT04565756
Last Updated: 2025-05-09
Results Overview
Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Assessed starting from Day 1 of treatment to Day 36 in Dose Escalation.
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Dose Escalation EXN407 Cohort 1
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation Pooled Placebo Cohort
Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4
|
Dose Expansion EXN407 Cohort
The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Expansion Placebo Cohort
Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
4
|
23
|
12
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
4
|
22
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dose Escalation EXN407 Cohort 1
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation Pooled Placebo Cohort
Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4
|
Dose Expansion EXN407 Cohort
The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Expansion Placebo Cohort
Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of EXN407
Baseline characteristics by cohort
| Measure |
Dose Escalation EXN407 Cohort 1
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3
n=3 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation Pooled Placebo Cohort
n=4 Participants
Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4
|
Dose Expansion EXN407 Cohort
n=23 Participants
The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Expansion Placebo Cohort
n=12 Participants
Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
67 years
n=5 Participants
|
59 years
n=4 Participants
|
63 years
n=21 Participants
|
59 years
n=10 Participants
|
61 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
23 participants
n=21 Participants
|
12 participants
n=10 Participants
|
48 participants
n=115 Participants
|
|
BCVA
|
83.3 BCVA (Letters)
STANDARD_DEVIATION 3.51 • n=5 Participants
|
83.0 BCVA (Letters)
STANDARD_DEVIATION 1.00 • n=7 Participants
|
71.3 BCVA (Letters)
STANDARD_DEVIATION 1.53 • n=5 Participants
|
86.3 BCVA (Letters)
STANDARD_DEVIATION 5.56 • n=4 Participants
|
81.3 BCVA (Letters)
STANDARD_DEVIATION 6.04 • n=21 Participants
|
83.6 BCVA (Letters)
STANDARD_DEVIATION 7.44 • n=10 Participants
|
82.1 BCVA (Letters)
STANDARD_DEVIATION 6.54 • n=115 Participants
|
|
Corneal thickness
|
561.3 microns
STANDARD_DEVIATION 62.80 • n=5 Participants
|
526.3 microns
STANDARD_DEVIATION 10.02 • n=7 Participants
|
581.7 microns
STANDARD_DEVIATION 53.31 • n=5 Participants
|
565.8 microns
STANDARD_DEVIATION 25.86 • n=4 Participants
|
555.6 microns
STANDARD_DEVIATION 33.75 • n=21 Participants
|
548.5 microns
STANDARD_DEVIATION 38.35 • n=10 Participants
|
553.2 microns
STANDARD_DEVIATION 34.99 • n=115 Participants
|
PRIMARY outcome
Timeframe: Assessed starting from Day 1 of treatment to Day 36 in Dose Escalation.Population: The Safety population comprised all randomised subjects who received any amount of study drug. Summaries, listings, and analyses were based on the treatment actually received. Screen failures and randomised subjects who did not receive any medication were excluded from the safety analysis set. The Safety population was used for the summaries of all safety assessments.
Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
n=3 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
n=3 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
n=3 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
n=4 Participants
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
n=4 Participants
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
n=4 Participants
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Primary Objective of the Study is to Evaluate the Ocular Safety and Tolerability (by Incidence of Ocular Adverse Events) of EXN407 Ophthalmic Solution in Dose Escalation Phase.
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase.Population: The Safety population comprised all randomised subjects who received any amount of study drug. Summaries, listings, and analyses were based on the treatment actually received. Screen failures and randomised subjects who did not receive any medication were excluded from the safety analysis set.
Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=23 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=23 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=23 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=12 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
n=12 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
n=12 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Primary Objective of the Study is to Evaluate the Ocular Safety and Tolerability (by Incidence of Ocular Adverse Events) of EXN407 Ophthalmic Solution in Dose Expansion Phase.
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Population: Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.
Measured by characterizing the PK profile by estimating the time of the maximum plasma drug concentration (Tmax) of EXN407 in plasma.
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=2 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=22 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by Tmax.
|
NA hour
Standard Deviation NA
Below the level of detection
|
0.5 hour
Standard Deviation 0
|
0.5 hour
Standard Deviation 0.000000000123
|
0.494 hour
Standard Deviation 0.276
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Population: Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.
Measured by characterizing the PK profile by estimating the maximum observed drug plasma concentration (Cmax) of EXN407 in plasma.
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=2 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=22 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by Cmax
|
NA ng/mL
Standard Deviation NA
Below the level of detection
|
0.0571 ng/mL
Standard Deviation 0
|
0.0831 ng/mL
Standard Deviation 0.0253
|
0.0883 ng/mL
Standard Deviation 0.0410
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Population: Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.
Measured by characterizing the PK profile by estimating the area under the curve (AUC) of EXN407 in plasma.
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=2 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=22 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by AUC.
|
NA hr*ng/mL
Standard Deviation NA
Below the level of detection
|
0.0368 hr*ng/mL
Standard Deviation 0
|
0.153 hr*ng/mL
Standard Deviation 0.205
|
0.0845 hr*ng/mL
Standard Deviation 0.112
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.Population: Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.
Measured by characterizing the PK profile by estimating the apparent elimination half-life (t½) of EXN407 in plasma.
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=2 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=22 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by t½.
|
NA hour
Standard Deviation NA
Below the level of detection
|
0 hour
Standard Deviation 0
|
0 hour
Standard Deviation 0
|
0 hour
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days/EOS in Dose Escalation and upto 4 months(113 days/EOS) in Dose Expansion.Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy (BCVA (Letters))
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
n=4 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
n=4 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
n=23 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
n=23 Participants
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
n=12 Participants
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
n=12 Participants
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate Changes in Ocular Functional Measures as Assessed Using Ophthalmoscopy.
|
-5.0 BCVA (Letters)
Standard Deviation 8.72
|
-5.0 BCVA (Letters)
Standard Deviation 9.54
|
-2.0 BCVA (Letters)
Standard Deviation 2.65
|
-1.0 BCVA (Letters)
Standard Deviation 3.61
|
3.0 BCVA (Letters)
Standard Deviation 2.0
|
-4.0 BCVA (Letters)
Standard Deviation 7.94
|
-1.3 BCVA (Letters)
Standard Deviation 3.3
|
-3.0 BCVA (Letters)
Standard Deviation 5.35
|
-0.1 BCVA (Letters)
Standard Deviation 3.54
|
-1.7 BCVA (Letters)
Standard Deviation 6.06
|
1.3 BCVA (Letters)
Standard Deviation 5.14
|
1.3 BCVA (Letters)
Standard Deviation 5.31
|
SECONDARY outcome
Timeframe: From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days/EOS in Dose Escalation and up to 4 months(113 days) in Dose Expansion.Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy (corneal thickness).
Outcome measures
| Measure |
Dose Escalation EXN407 Cohort 1 Study Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1 Contralateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 1, Bilateral Eye
n=3 Participants
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Study Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Contralateral Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2 Bilateral Eye
n=3 Participants
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Study Eye
n=4 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Contralateral Eye
n=4 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3 Bilateral Eye
n=23 Participants
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye
n=23 Participants
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye
n=12 Participants
Data from the placebo subjects was pooled (as appropriate).
|
Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye
n=12 Participants
Data from the placebo subjects was pooled (as appropriate).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate Changes in Ocular Structural Measures as Assessed Using Ophthalmoscopy.
|
-5.0 corneal thickness (microns)
Standard Deviation 6.93
|
-2.7 corneal thickness (microns)
Standard Deviation 8.33
|
15.3 corneal thickness (microns)
Standard Deviation 7.02
|
11.0 corneal thickness (microns)
Standard Deviation 19.08
|
-3.0 corneal thickness (microns)
Standard Deviation 4.00
|
-10.3 corneal thickness (microns)
Standard Deviation 18.93
|
-0.8 corneal thickness (microns)
Standard Deviation 3.77
|
1.3 corneal thickness (microns)
Standard Deviation 4.50
|
0.2 corneal thickness (microns)
Standard Deviation 8.61
|
0.1 corneal thickness (microns)
Standard Deviation 10.52
|
2.4 corneal thickness (microns)
Standard Deviation 11.27
|
0.5 corneal thickness (microns)
Standard Deviation 11.35
|
Adverse Events
Dose Escalation EXN407 Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Escalation EXN407 Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Escalation EXN407 Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Escalation Pooled Placebo Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Expansion EXN407 Cohort
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose Expansion Placebo Cohort
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation EXN407 Cohort 1
n=3 participants at risk
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2
n=3 participants at risk
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3
n=3 participants at risk
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation Pooled Placebo Cohort
n=4 participants at risk
Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4
|
Dose Expansion EXN407 Cohort
n=23 participants at risk
The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Expansion Placebo Cohort
n=12 participants at risk
Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
4.3%
1/23 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Cardiac disorders
non-ST elevation acute coronary syndrome
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
4.3%
1/23 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Metabolism and nutrition disorders
severe hypoglycaemia
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
Other adverse events
| Measure |
Dose Escalation EXN407 Cohort 1
n=3 participants at risk
Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 2
n=3 participants at risk
Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation EXN407 Cohort 3
n=3 participants at risk
Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Escalation Pooled Placebo Cohort
n=4 participants at risk
Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4
|
Dose Expansion EXN407 Cohort
n=23 participants at risk
The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses
EXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
|
Dose Expansion Placebo Cohort
n=12 participants at risk
Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
33.3%
1/3 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Blepharitis
|
33.3%
1/3 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.7%
2/23 • Number of events 2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
33.3%
1/3 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
33.3%
1/3 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
13.0%
3/23 • Number of events 3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.7%
2/23 • Number of events 2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.7%
2/23 • Number of events 2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.7%
2/23 • Number of events 2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Episcleritis
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
25.0%
1/4 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/12 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
16.7%
2/12 • Number of events 2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
16.7%
2/12 • Number of events 2 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Punctate keratiis
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Cataract cortical
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/3 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/4 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
0.00%
0/23 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
8.3%
1/12 • Number of events 1 • Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period
Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place