Trial Outcomes & Findings for TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) (NCT NCT03093701)

NCT ID: NCT03093701

Last Updated: 2021-12-23

Results Overview

Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye. Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: 6 months after dosing
• Results posted on: 2021-12-23

Participant Flow

Participant milestones

Measure	Group 1 TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 2 TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 3 TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 4 TLC399 (ProDex) 0.84 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid
Overall Study STARTED	10	10	11	0
Overall Study COMPLETED	10	7	11	0
Overall Study NOT COMPLETED	0	3	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TLC399 (ProDex) in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

Baseline characteristics by cohort

Measure	Group 1 n=10 Participants TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 2 n=10 Participants TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 3 n=11 Participants TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Total n=31 Participants Total of all reporting groups
Age, Continuous	72.1 years STANDARD_DEVIATION 10.40 • n=5 Participants	63.5 years STANDARD_DEVIATION 12.55 • n=7 Participants	68.5 years STANDARD_DEVIATION 8.20 • n=5 Participants	68.1 years STANDARD_DEVIATION 10.70 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	11 participants n=5 Participants	31 participants n=4 Participants
RVO Type BRVO	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
RVO Type CRVO	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
CST (study eye)	530.6 µm STANDARD_DEVIATION 133.56 • n=5 Participants	776.9 µm STANDARD_DEVIATION 288.67 • n=7 Participants	702.1 µm STANDARD_DEVIATION 195.15 • n=5 Participants	670.9 µm STANDARD_DEVIATION 231.75 • n=4 Participants
BCVA (study eye)	61.5 letters STANDARD_DEVIATION 7.40 • n=5 Participants	48.2 letters STANDARD_DEVIATION 16.94 • n=7 Participants	51.1 letters STANDARD_DEVIATION 16.66 • n=5 Participants	53.5 letters STANDARD_DEVIATION 15.10 • n=4 Participants
IOP (study eye)	12.4 mmHg STANDARD_DEVIATION 2.63 • n=5 Participants	13.5 mmHg STANDARD_DEVIATION 3.41 • n=7 Participants	13.6 mmHg STANDARD_DEVIATION 2.69 • n=5 Participants	13.2 mmHg STANDARD_DEVIATION 2.88 • n=4 Participants

PRIMARY outcome

Timeframe: 6 months after dosing

Population: The analysis population was based on subject's randomized treatment group.

Proportion of subjects with BCVA gain of 15 or more letters from baseline in the study eye.

Patients who received rescue medication/procedures within 6 months after the study treatment was initiated were considered failure to achieve a gain of at least 15 BCVA letters.

Outcome measures

Measure	Group 1 n=10 Participants TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 2 n=10 Participants TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 3 n=11 Participants TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid
Proportion of Subjects With BCVA Gain of 15 or More Letters From Baseline in the Study Eye	1 Participants	1 Participants	1 Participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Group 2

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Group 3

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=10 participants at risk TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 2 n=8 participants at risk TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 3 n=13 participants at risk TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid
Eye disorders Vitreous haze	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vitreous haze leading to significant vision loss	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Nervous system disorders Transient ischaemic attack	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Pneumonia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Gastrointestinal disorders Acute coliti	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Cardiac disorders Pericardial effusion	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.

Other adverse events

Measure	Group 1 n=10 participants at risk TLC399 (ProDex) 0.36mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 2 n=8 participants at risk TLC399 (ProDex) 0.6 mg DSP with 100 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid	Group 3 n=13 participants at risk TLC399 (ProDex) 0.6 mg DSP with 50 mM PL TLC399 (ProDex): 2-vial system: TLC399-DSP and TLC399-Lipid
Eye disorders Vitrous detachment	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	25.0% 2/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Anterior chamber flare	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Cataract	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vitreous haze	100.0% 10/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	100.0% 8/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	100.0% 13/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Macular oedema	40.0% 4/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	25.0% 2/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	38.5% 5/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Visual acuity reduced	40.0% 4/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	50.0% 4/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Conjunctival haemorrhage	40.0% 4/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	25.0% 2/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vitreous floaters	20.0% 2/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	25.0% 2/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vision blurred	30.0% 3/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Corneal oedema	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal vein occlusion	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Optic disc hyperaemia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal aneurysm	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal vascular disorder	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Visual imparment	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Cataract nulcear	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Conjunctival cyst	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Dry eye	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Eye pain	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Iris neovascularisation	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Macular fibrosis	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Macular pigmentation	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Maculopathy	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal disorder	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal exudates	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal haemorrhage	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal neovascularisation	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal scar	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vitreous disorder	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vitreous haemorrhage	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Vitreous opacities	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Eye disorders Retinal thickening	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Intraocular pressure increased	20.0% 2/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	37.5% 3/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	30.8% 4/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Medication residue present	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Blood creatinine increased	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Alanine aminotransferase increased	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Aspartate aminotransferase increased	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Blood potassium increased	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Gamma-glutamyltransferase increased	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Blood alkaline phosphatase increased	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Blood cholesterol increased	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Blood urea increased	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Cardiac murmur	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Haemoglobin decreased	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Investigations Heart rate irregular	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Nasopharyngitis	20.0% 2/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Urinary tract infection	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Bronchitis	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Pneumonia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Infections and infestations Sepsis	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Vascular disorders Hypertension	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	23.1% 3/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Vascular disorders Hypotension	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Gastrointestinal disorders Nausea	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Gastrointestinal disorders Vomiting	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Gastrointestinal disorders Colitis	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Gastrointestinal disorders Hiatus hernia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	15.4% 2/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Renal and urinary disorders Glycosuria	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Renal and urinary disorders Nephropathy	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Renal and urinary disorders Renal artery occlusion	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Renal and urinary disorders Urine abnormality	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Injury, poisoning and procedural complications Fall	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	12.5% 1/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Nervous system disorders Carotid artery stenosis	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Nervous system disorders Dementia	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Nervous system disorders Transient ischaemic attack	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Cardiac disorders Cardiomyopathy	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Cardiac disorders Pericardial effusion	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
General disorders Oedema peripheral	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Ear and labyrinth disorders Tinnitus	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/10 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	0.00% 0/8 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.	7.7% 1/13 • 14 days (screening) + 1 year Other (Not including serious) Adverse Events include both ocular (study eye only) and non-ocular adverse events. The safety population for AE reporting/analysis was based on the actual treatments received by the subjects.

Additional Information

Dr. Carl Brown

Taiwan Liposome Company

Phone: 886-2-2655-7377

Email: tlc_clinicaltrials@tlcbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place