Trial Outcomes & Findings for Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD) (NCT NCT02418754)

NCT ID: NCT02418754

Last Updated: 2020-10-26

Results Overview

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 505 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2020-10-26

Participant Flow

The study was conducted at 82 sites in US and 11 sites in Japan. A total of 804 participants were screened. Out of 804 participants, 505 were randomized and treated.

Participants were initially randomized in a 1:2:2 ratio to receive REGN2176-3 (1 mg:2 mg) (REGN2176 1 mg:REGN3 2 mg) or REGN2176-3 (3 mg:2 mg) (REGN2176 3 mg:REGN3 2 mg) or 2 mg intravitreal aflibercept injection (IAI). One eye was under study (the fellow eye was assessed for safety only).

Unit of analysis: Study Eyes

Participant milestones

Measure	Group 1: REGN2176-3 (1 mg:2 mg) Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.	Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg) IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Period 1 (Day 1 to Week 12) STARTED	103 103	200 200	202 202	0 0	0 0
Period 1 (Day 1 to Week 12) COMPLETED	101 101	196 196	200 200	0 0	0 0
Period 1 (Day 1 to Week 12) NOT COMPLETED	2 2	4 4	2 2	0 0	0 0
Period 2 (Day 1 to Week 52/End of Study) STARTED	103 103	106 106	108 108	94 94	94 94
Period 2 (Day 1 to Week 52/End of Study) COMPLETED	70 70	64 64	71 71	67 67	67 67
Period 2 (Day 1 to Week 52/End of Study) NOT COMPLETED	33 33	42 42	37 37	27 27	27 27

Reasons for withdrawal

Measure	Group 1: REGN2176-3 (1 mg:2 mg) Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.	Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg) IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Period 1 (Day 1 to Week 12) Adverse Event	0	2	0	0	0
Period 1 (Day 1 to Week 12) Death	1	0	0	0	0
Period 1 (Day 1 to Week 12) Physician Decision	1	0	0	0	0
Period 1 (Day 1 to Week 12) Withdrawal by Subject	0	2	1	0	0
Period 1 (Day 1 to Week 12) Lost to Follow-up	0	0	1	0	0
Period 2 (Day 1 to Week 52/End of Study) Adverse Event	3	7	6	2	2
Period 2 (Day 1 to Week 52/End of Study) Death	1	0	0	0	0
Period 2 (Day 1 to Week 52/End of Study) Physician Decision	26	28	26	21	24
Period 2 (Day 1 to Week 52/End of Study) Withdrawal by Subject	3	4	4	1	0
Period 2 (Day 1 to Week 52/End of Study) Lost to Follow-up	0	2	1	2	1
Period 2 (Day 1 to Week 52/End of Study) Other Un-specified	0	1	0	1	0

Baseline Characteristics

Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

Baseline characteristics by cohort

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=200 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=202 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Total n=505 Participants Total of all reporting groups
Age, Continuous	79.2 years STANDARD_DEVIATION 8.01 • n=5 Participants	78.6 years STANDARD_DEVIATION 8.77 • n=7 Participants	77.7 years STANDARD_DEVIATION 8.61 • n=5 Participants	78.3 years STANDARD_DEVIATION 8.56 • n=4 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	121 Participants n=7 Participants	135 Participants n=5 Participants	317 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	79 Participants n=7 Participants	67 Participants n=5 Participants	188 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants n=5 Participants	193 Participants n=7 Participants	196 Participants n=5 Participants	491 Participants n=4 Participants
Ethnicity (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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	189 Participants n=7 Participants	186 Participants n=5 Participants	473 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	98 Participants n=5 Participants	193 Participants n=7 Participants	194 Participants n=5 Participants	485 Participants n=4 Participants
Region of Enrollment Japan	5 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set (FAS) that included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data.

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=200 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=202 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12	5.9 Letters Standard Error 1.01	5.7 Letters Standard Error 0.73	7.4 Letters Standard Error 0.72

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on FAS. LOCF method was used to impute missing data.

CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=200 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=202 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 12, as Measured by Optical Coherence Tomography (OCT)	-131.1 Microns Standard Error 6.88	-116.9 Microns Standard Error 4.96	-134.4 Microns Standard Error 4.92

SECONDARY outcome

Timeframe: Week 12

Population: Analysis was performed on FAS. LOCF method was used to impute missing data.

CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=200 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=202 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Percentage of Participants With Complete Resolution of Intraretinal and Subretinal Fluid From Baseline at Week 12 Measured by Optical Coherence Tomography (OCT)	35.0 Percentage of Participants	24.0 Percentage of Participants	42.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on FAS. LOCF was used to impute missing data. Here, number of participants analyzed = participants with available data for this outcome measure.

The anatomical state of the retinal vasculature of the study eye and the fellow eye was evaluated by funduscopic examination, fundus photography and FA to evaluate the total lesion area, CNV area, classic CNV area, and fluorescein leakage. CNV area values measured in square millimeters, each disc area was equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=97 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=187 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=192 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 Measured by Fluorescein Angiography (FA)	-3.4 Square Millimeter (mm^2) Standard Error 0.44	-2.0 Square Millimeter (mm^2) Standard Error 0.31	-3.6 Square Millimeter (mm^2) Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on FAS. LOCF was used to impute missing data. Here, number of participants analyzed = participants with available data for this outcome measure.

Total Lesion Size was assessed by Fluorescein Angiography.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=97 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=187 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=192 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Change From Baseline in Total Lesion Size at Week 12 Measured by Fluorescein Angiography (FA)	-3.1 mm Standard Error 0.43	-2.1 mm Standard Error 0.31	-3.5 mm Standard Error 0.31

SECONDARY outcome

Timeframe: Week 12

Population: Analysis was performed on FAS. LOCF was used to impute missing data.

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at Week 12 compared with baseline.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=200 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=202 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Percentage of Participants Who Gained At Least 15 Letters in BCVA From Baseline at Week 12, Measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)	11.7 Percentage of Participants	18.5 Percentage of Participants	21.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on FAS. LOCF was used to impute missing data. Here, number of participants analyzed = participants with available data for this outcome measure.

SHM was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=94 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=191 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=193 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Percent Change From Baseline in Subretinal Hyperreflectivity Material (SHM) at Week 12 Measured by Optical Coherence Tomography (OCT)	-50.0 Percent change Standard Error 5.94	-41.9 Percent change Standard Error 4.17	-48.8 Percent change Standard Error 4.14

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis was performed on FAS. LOCF was used to impute missing data.

CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.

Outcome measures

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 Participants Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=200 Participants Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=202 Participants IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Change From Baseline in Central Retinal/Lesion Thickness at Week 12 Measured by Optical Coherence Tomography (OCT)	-150.7 Microns Standard Error 7.40	-139.6 Microns Standard Error 5.32	-160.4 Microns Standard Error 5.29

Adverse Events

Group 1: REGN2176-3 (1 mg:2 mg)

Serious events: 17 serious events

Other events: 48 other events

Deaths: 3 deaths

Group 2: REGN2176-3 (3 mg:2 mg)

Serious events: 20 serious events

Other events: 50 other events

Deaths: 2 deaths

Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg

Serious events: 23 serious events

Other events: 51 other events

Deaths: 3 deaths

Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg

Serious events: 17 serious events

Other events: 52 other events

Deaths: 1 deaths

Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg)

Serious events: 15 serious events

Other events: 52 other events

Deaths: 1 deaths

Serious adverse events

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 participants at risk Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=106 participants at risk Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=108 participants at risk IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg n=94 participants at risk Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.	Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg) n=94 participants at risk IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Blood and lymphatic system disorders Anaemia	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Acute coronary syndrome	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Acute myocardial infarction	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Atrial fibrillation	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	4.3% 4/94 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Bradycardia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Cardiac failure congestive	2.9% 3/103 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Cardio-Respiratory arrest	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Cardiomyopathy	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Coronary artery disease	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Ischaemic cardiomyopathy	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Pericardial effusion	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Cardiac disorders Stress cardiomyopathy	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Blindness	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Blindness transient	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Macular degeneration	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Neovascular age-related macular degeneration	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Open angle glaucoma	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Retinal haemorrhage	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.1% 2/94 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Uveitis	0.97% 1/103 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/106 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Visual acuity reduced	1.9% 2/103 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Gastrointestinal disorders Ileus	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Gastrointestinal disorders Large intestine polyp	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
General disorders Chest pain	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
General disorders Death	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
General disorders Non-Cardiac chest pain	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Hepatobiliary disorders Hepatitis acute	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Bronchitis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Device related infection	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Diverticulitis	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Endophthalmitis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Gastroenteritis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Infectious colitis	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Osteomyelitis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Pneumonia	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.2% 3/94 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Sepsis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/106 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Staphylococcal bacteraemia	0.97% 1/103 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Urinary tract infection	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Vestibular neuronitis	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Back injury	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Fall	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/106 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.2% 3/94 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/106 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Impacted fracture	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Investigations Blood pressure increased	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Metabolism and nutrition disorders Dehydration	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small cell lung cancer	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage ii	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Basal ganglia stroke	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Carotid artery stenosis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Cerebrovascular accident	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Dementia alzheimer's type	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Dysarthria	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Encephalopathy	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Hypoaesthesia	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Metabolic encephalopathy	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Syncope	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Nervous system disorders Tremor	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Psychiatric disorders Major depression	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Renal and urinary disorders Acute kidney injury	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Renal and urinary disorders Calculus ureteric	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Renal and urinary disorders Haematuria	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.97% 1/103 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.97% 1/103 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Vascular disorders Hypotension	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Vascular disorders Peripheral ischaemia	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Vascular disorders Shock haemorrhagic	0.00% 0/103 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.

Other adverse events

Measure	Group 1: REGN2176-3 (1 mg:2 mg) n=103 participants at risk Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, Group 1 continued without a secondary randomization. After Week 12, dosing in Group 1 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 2: REGN2176-3 (3 mg:2 mg) n=106 participants at risk Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 2 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 3: Intravitreal Aflibercept Injection (IAI) 2 mg n=108 participants at risk IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 3 was monthly up to Week 28, then criteria based re-dosing from Week 28-52.	Group 4: REGN2176-3 (3 mg:2 mg) to IAI 2 mg n=94 participants at risk Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 2 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 4 was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.	Group 5: IAI 2 mg to REGN2176-3 (3 mg:2 mg) n=94 participants at risk IAI every 4 weeks for 12 weeks. At Week 12, a secondary randomization occurred in Group 3 for those participants who completed the Week 12 assessments. After Week 12, dosing in Group 5 was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Eye disorders Cataract	5.8% 6/103 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.1% 1/94 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/94 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Conjunctival haemorrhage	5.8% 6/103 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.8% 4/106 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.6% 6/108 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	11.7% 11/94 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	9.6% 9/94 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Eye pain	2.9% 3/103 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	4.7% 5/106 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.93% 1/108 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	6.4% 6/94 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.1% 2/94 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Neovascular age-related macular degeneration	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	9.4% 10/106 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	7.4% 8/108 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	8.5% 8/94 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.3% 5/94 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Posterior capsule opacification	4.9% 5/103 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.94% 1/106 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.3% 5/94 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.1% 2/94 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Retinal haemorrhage	5.8% 6/103 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	7.5% 8/106 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.8% 3/108 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.3% 5/94 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.2% 3/94 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Vitreous detachment	2.9% 3/103 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.8% 3/106 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	7.4% 7/94 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.2% 3/94 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Eye disorders Vitreous floaters	1.9% 2/103 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	4.3% 4/94 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.3% 5/94 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Nasopharyngitis	2.9% 3/103 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.7% 6/106 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	8.3% 9/108 • Number of events 12 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.3% 5/94 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	8.5% 8/94 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Sinusitis	1.9% 2/103 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	6.6% 7/106 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	4.3% 4/94 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	7.4% 7/94 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Infections and infestations Urinary tract infection	6.8% 7/103 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	6.6% 7/106 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.7% 4/108 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	7.4% 7/94 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	13.8% 13/94 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Injury, poisoning and procedural complications Fall	4.9% 5/103 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.7% 6/106 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	4.3% 4/94 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.2% 3/94 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Vascular disorders Hypertension	5.8% 6/103 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	3.8% 4/106 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	9.3% 10/108 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.1% 2/94 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	5.3% 5/94 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.
Gastrointestinal disorders Nausea	2.9% 3/103 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	0.00% 0/106 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	1.9% 2/108 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	2.1% 2/94 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.	6.4% 6/94 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 52) regardless of seriousness or relationship to investigational product. Reported AEs are treatment-emergent and are defined as AEs starting after the first study eye injection and no later than 30 days after the last study eye or fellow eye injection. Analysis was performed on safety analysis set (SAF) and included all initially randomized participants who received any study drug before Week 12; it was based on Week 12 secondary randomization group assignment.

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER