Trial Outcomes & Findings for Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (NCT NCT03810313)

NCT ID: NCT03810313

Last Updated: 2023-01-30

Results Overview

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 493 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2023-01-30

Participant Flow

Participants were recruited from 132 sites in 19 countries

The study comprised a screening period of 28 days

Participant milestones

Measure	Brolucizumab 6 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Overall Study STARTED	247	246
Overall Study COMPLETED	66	70
Overall Study NOT COMPLETED	181	176

Reasons for withdrawal

Measure	Brolucizumab 6 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Overall Study Study terminated by sponsor	164	159
Overall Study Subject decision	10	11
Overall Study Lost to Follow-up	3	3
Overall Study Adverse Event	2	1
Overall Study Death	2	1
Overall Study Physician Decision	0	1

Baseline Characteristics

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

Baseline characteristics by cohort

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Total n=493 Participants Total of all reporting groups
Age, Continuous	63.0 Years STANDARD_DEVIATION 13.69 • n=5 Participants	65.2 Years STANDARD_DEVIATION 12.66 • n=7 Participants	64.1 Years STANDARD_DEVIATION 13.22 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	96 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	151 Participants n=5 Participants	150 Participants n=7 Participants	301 Participants n=5 Participants
Race/Ethnicity, Customized White	176 Participants n=5 Participants	178 Participants n=7 Participants	354 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	62 Participants n=5 Participants	58 Participants n=7 Participants	120 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Full Analysis Set (FAS) included all randomized subjects who received at least one Intravitreal injection of the study treatment.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24	13.2 Letters read Standard Error 0.85	16.0 Letters read Standard Error 0.85

SECONDARY outcome

Timeframe: Baseline, Week 40 to Week 52

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.

An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=120 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=120 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in BCVA Averaged Over Week 40 to Week 52	13.4 Letters read Standard Deviation 15.73	15.4 Letters read Standard Deviation 13.96

SECONDARY outcome

Timeframe: Baseline, Week 64 to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period.

An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=109 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=113 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in BCVA Averaged Over Week 64 to Week 76	14.0 Letters read Standard Deviation 16.39	16.9 Letters read Standard Deviation 13.60

SECONDARY outcome

Timeframe: Baseline and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in BCVA by Visit up to Week 76 Week 4	11.3 Letters read Standard Deviation 12.30	12.8 Letters read Standard Deviation 11.00
Change From Baseline in BCVA by Visit up to Week 76 Week 8	13.6 Letters read Standard Deviation 13.77	15.0 Letters read Standard Deviation 11.78
Change From Baseline in BCVA by Visit up to Week 76 Week 12	14.1 Letters read Standard Deviation 14.17	16.3 Letters read Standard Deviation 12.78
Change From Baseline in BCVA by Visit up to Week 76 Week 16	13.3 Letters read Standard Deviation 15.37	17.4 Letters read Standard Deviation 13.54
Change From Baseline in BCVA by Visit up to Week 76 Week 20	13.9 Letters read Standard Deviation 14.17	17.6 Letters read Standard Deviation 14.68
Change From Baseline in BCVA by Visit up to Week 76 Week 24	13.6 Letters read Standard Deviation 14.69	18.1 Letters read Standard Deviation 13.83
Change From Baseline in BCVA by Visit up to Week 76 Week 28	12.7 Letters read Standard Deviation 15.52	16.2 Letters read Standard Deviation 13.55
Change From Baseline in BCVA by Visit up to Week 76 Week 32	11.5 Letters read Standard Deviation 15.96	15.1 Letters read Standard Deviation 14.58
Change From Baseline in BCVA by Visit up to Week 76 Week 36	12.6 Letters read Standard Deviation 17.17	15.3 Letters read Standard Deviation 14.05
Change From Baseline in BCVA by Visit up to Week 76 Week 40	13.7 Letters read Standard Deviation 15.35	16.7 Letters read Standard Deviation 12.62
Change From Baseline in BCVA by Visit up to Week 76 Week 44	13.7 Letters read Standard Deviation 16.59	15.4 Letters read Standard Deviation 14.50
Change From Baseline in BCVA by Visit up to Week 76 Week 48	13.5 Letters read Standard Deviation 17.11	16.2 Letters read Standard Deviation 13.14
Change From Baseline in BCVA by Visit up to Week 76 Week 52	12.9 Letters read Standard Deviation 18.00	16.3 Letters read Standard Deviation 14.13
Change From Baseline in BCVA by Visit up to Week 76 Week 56	13.4 Letters read Standard Deviation 16.98	14.9 Letters read Standard Deviation 16.43
Change From Baseline in BCVA by Visit up to Week 76 Week 60	13.1 Letters read Standard Deviation 18.75	15.7 Letters read Standard Deviation 13.93
Change From Baseline in BCVA by Visit up to Week 76 Week 64	14.2 Letters read Standard Deviation 17.06	17.8 Letters read Standard Deviation 13.54
Change From Baseline in BCVA by Visit up to Week 76 Week 68	14.2 Letters read Standard Deviation 16.75	17.0 Letters read Standard Deviation 13.88
Change From Baseline in BCVA by Visit up to Week 76 Week 72	15.8 Letters read Standard Deviation 14.55	15.2 Letters read Standard Deviation 15.09
Change From Baseline in BCVA by Visit up to Week 76 Week 76	17.2 Letters read Standard Deviation 13.46	14.9 Letters read Standard Deviation 13.76

SECONDARY outcome

Timeframe: Baseline and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.

The summary by visit was conducted based on the BCVA observed from each of the corresponding visits.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Every 5 letters represents 1 line of vision on the reading chart.

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA gain from baseline >=10	134 Participants	141 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA gain from baseline >=15	101 Participants	109 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA gain from baseline >=5	181 Participants	189 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA gain from baseline >=10	138 Participants	132 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA gain from baseline >=15	92 Participants	86 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA gain from baseline >=5	177 Participants	183 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA gain from baseline >=10	143 Participants	151 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA gain from baseline >=15	103 Participants	95 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA gain from baseline >=5	161 Participants	164 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA gain from baseline >=5	144 Participants	152 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA gain from baseline >=10	121 Participants	134 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA gain from baseline >=15	91 Participants	104 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA gain from baseline >=5	135 Participants	136 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA gain from baseline >=10	114 Participants	122 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA gain from baseline >=15	83 Participants	101 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA gain from baseline >=5	125 Participants	130 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA gain from baseline >=10	101 Participants	115 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA gain from baseline >=15	78 Participants	97 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA gain from baseline >=5	112 Participants	116 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA gain from baseline >=10	91 Participants	104 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA gain from baseline >=15	69 Participants	83 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA gain from baseline >=5	100 Participants	100 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA gain from baseline >=10	78 Participants	89 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA gain from baseline >=15	58 Participants	76 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA gain from baseline >=5	101 Participants	104 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA gain from baseline >=10	86 Participants	84 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA gain from baseline >=15	61 Participants	69 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA gain from baseline >=5	101 Participants	98 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA gain from baseline >=10	85 Participants	85 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA gain from baseline >=15	59 Participants	71 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA gain from baseline >=5	89 Participants	99 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA gain from baseline >=10	75 Participants	82 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA gain from baseline >=15	59 Participants	67 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA gain from baseline >=5	92 Participants	89 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA gain from baseline >=10	72 Participants	79 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA gain from baseline >=15	56 Participants	63 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA gain from baseline >=5	89 Participants	92 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA gain from baseline >=10	71 Participants	81 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA gain from baseline >=15	58 Participants	67 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA gain from baseline >=5	88 Participants	92 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA gain from baseline >=10	70 Participants	82 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA gain from baseline >=15	58 Participants	64 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA gain from baseline >=5	88 Participants	91 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA gain from baseline >=10	72 Participants	80 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA gain from baseline >=15	60 Participants	69 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA gain from baseline >=5	88 Participants	89 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA gain from baseline >=10	73 Participants	81 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA gain from baseline >=15	59 Participants	65 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA gain from baseline >=5	76 Participants	84 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA gain from baseline >=10	61 Participants	72 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA gain from baseline >=15	52 Participants	62 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA gain from baseline >=5	65 Participants	63 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA gain from baseline >=10	53 Participants	60 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA gain from baseline >=15	46 Participants	50 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA gain from baseline >=5	54 Participants	56 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA gain from baseline >=10	47 Participants	49 Participants
Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA gain from baseline >=15	36 Participants	41 Participants

SECONDARY outcome

Timeframe: Baseline and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit.

The summary by visit was conducted based on the BCVA observed from each of the corresponding visit.

BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters.

Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.

Every 5 letters represents 1 line of vision on the reading chart.

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA loss from baseline >=15	6 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA loss from baseline >=5	8 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA loss from baseline >=10	6 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA loss from baseline >=5	5 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA loss from baseline >=10	5 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 68; BCVA loss from baseline >=15	3 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA loss from baseline >=5	3 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA loss from baseline >=10	3 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA loss from baseline >=15	1 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA loss from baseline >=10	6 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA loss from baseline >=15	5 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA loss from baseline >=15	5 Participants	1 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA loss from baseline >=15	8 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA loss from baseline >=15	5 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA loss from baseline >=10	9 Participants	8 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA loss from baseline >=5	9 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA loss from baseline >=10	7 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA loss from baseline >=10	7 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA loss from baseline >=10	6 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA loss from baseline >=15	5 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA loss from baseline >=5	11 Participants	10 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 60; BCVA loss from baseline >=10	8 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 64; BCVA loss from baseline >=15	6 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 72; BCVA loss from baseline >=15	3 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA loss from baseline >=5	1 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 76; BCVA loss from baseline >=10	1 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA loss from baseline >=15	4 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA loss from baseline >=5	8 Participants	9 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA loss from baseline >=10	7 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 44; BCVA loss from baseline >=15	6 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA loss from baseline >=5	9 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 48; BCVA loss from baseline >=15	6 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA loss from baseline >=5	9 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 52; BCVA loss from baseline >=15	7 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 56; BCVA loss from baseline >=5	9 Participants	9 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA loss from baseline >=5	10 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 4; BCVA loss from baseline >=10	8 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA loss from baseline >=5	9 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA loss from baseline >=10	7 Participants	3 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 8; BCVA loss from baseline >=15	6 Participants	2 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA loss from baseline >=5	9 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 12; BCVA loss from baseline >=10	6 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA loss from baseline >=5	11 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 16; BCVA loss from baseline >=10	8 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA loss from baseline >=5	6 Participants	8 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 20; BCVA loss from baseline >=10	5 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA loss from baseline >=5	10 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA loss from baseline >=10	8 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 24; BCVA loss from baseline >=15	7 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA loss from baseline >=5	10 Participants	7 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA loss from baseline >=10	6 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 28; BCVA loss from baseline >=15	6 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA loss from baseline >=5	11 Participants	11 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 32; BCVA loss from baseline >=15	5 Participants	4 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA loss from baseline >=10	8 Participants	6 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 36; BCVA loss from baseline >=15	6 Participants	5 Participants
Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline Week 40; BCVA loss from baseline >=5	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Week 40 to Week 52

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point

Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52, measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=119 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=120 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in CSFT Averaged Over Week 40 to Week 52	-399.9 μm Standard Deviation 259.22	-434.6 μm Standard Deviation 261.71

SECONDARY outcome

Timeframe: Baseline, Week 64 to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point

Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=108 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=112 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in CSFT Averaged Over Week 64 to Week 76	-411.6 μm Standard Deviation 259.16	-445.7 μm Standard Deviation 259.73

SECONDARY outcome

Timeframe: Baseline, and every 4 weeks from baseline up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had CSFT data available on baseline and the specific post-baseline visit.

Change from baseline in central subfield thickness (CSFT) measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in CSFT by Visit up to Week 76 Week 4	-429.5 μm Standard Deviation 254.32	-420.6 μm Standard Deviation 242.68
Change From Baseline in CSFT by Visit up to Week 76 Week 8	-448.8 μm Standard Deviation 265.16	-436.1 μm Standard Deviation 255.53
Change From Baseline in CSFT by Visit up to Week 76 Week 16	-450.1 μm Standard Deviation 278.67	-470.7 μm Standard Deviation 255.64
Change From Baseline in CSFT by Visit up to Week 76 Week 20	-458.1 μm Standard Deviation 270.26	-470.2 μm Standard Deviation 260.46
Change From Baseline in CSFT by Visit up to Week 76 Week 24	-446.8 μm Standard Deviation 274.39	-472.4 μm Standard Deviation 249.20
Change From Baseline in CSFT by Visit up to Week 76 Week 28	-383.2 μm Standard Deviation 248.81	-417.9 μm Standard Deviation 269.03
Change From Baseline in CSFT by Visit up to Week 76 Week 32	-323.5 μm Standard Deviation 322.95	-395.8 μm Standard Deviation 299.16
Change From Baseline in CSFT by Visit up to Week 76 Week 48	-411.5 μm Standard Deviation 281.09	-457.8 μm Standard Deviation 261.08
Change From Baseline in CSFT by Visit up to Week 76 Week 52	-411.3 μm Standard Deviation 276.21	-457.0 μm Standard Deviation 256.40
Change From Baseline in CSFT by Visit up to Week 76 Week 56	-384.6 μm Standard Deviation 313.93	-400.8 μm Standard Deviation 298.50
Change From Baseline in CSFT by Visit up to Week 76 Week 60	-396.1 μm Standard Deviation 295.96	-438.8 μm Standard Deviation 254.36
Change From Baseline in CSFT by Visit up to Week 76 Week 64	-425.2 μm Standard Deviation 266.66	-462.3 μm Standard Deviation 258.08
Change From Baseline in CSFT by Visit up to Week 76 Week 68	-396.3 μm Standard Deviation 282.85	-416.1 μm Standard Deviation 260.79
Change From Baseline in CSFT by Visit up to Week 76 Week 72	-401.5 μm Standard Deviation 276.50	-419.0 μm Standard Deviation 252.10
Change From Baseline in CSFT by Visit up to Week 76 Week 76	-421.9 μm Standard Deviation 261.63	-408.5 μm Standard Deviation 251.12
Change From Baseline in CSFT by Visit up to Week 76 Week 12	-468.3 μm Standard Deviation 269.55	-440.7 μm Standard Deviation 251.74
Change From Baseline in CSFT by Visit up to Week 76 Week 36	-387.8 μm Standard Deviation 280.75	-406.5 μm Standard Deviation 265.67
Change From Baseline in CSFT by Visit up to Week 76 Week 40	-403.9 μm Standard Deviation 269.68	-446.6 μm Standard Deviation 270.47
Change From Baseline in CSFT by Visit up to Week 76 Week 44	-404.0 μm Standard Deviation 311.37	-418.4 μm Standard Deviation 271.33

SECONDARY outcome

Timeframe: Every 4 weeks from week 4 up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had data at each time point

Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 4	101 Participants	105 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 16	37 Participants	43 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 20	34 Participants	31 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 24	26 Participants	30 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 32	63 Participants	55 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 36	43 Participants	59 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 40	32 Participants	40 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 48	36 Participants	40 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 52	35 Participants	40 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 56	42 Participants	48 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 60	36 Participants	39 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 64	29 Participants	41 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 68	36 Participants	40 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 72	25 Participants	27 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 76	24 Participants	31 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 8	54 Participants	68 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 12	38 Participants	54 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 28	44 Participants	56 Participants
Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 Week 44	38 Participants	48 Participants

SECONDARY outcome

Timeframe: Every 4 weeks from week 4 up to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had non-missing CSFT assessment at the corresponding visit

Central subfield thickness (CSFT) is measured in μm by Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 4	157 Participants	137 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 8	168 Participants	155 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 12	172 Participants	149 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 16	153 Participants	141 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 20	147 Participants	135 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 24	135 Participants	123 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 28	107 Participants	90 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 32	81 Participants	74 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 36	83 Participants	77 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 40	94 Participants	86 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 44	83 Participants	79 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 48	82 Participants	83 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 52	85 Participants	82 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 56	74 Participants	71 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 60	81 Participants	79 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 64	85 Participants	80 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 68	65 Participants	69 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 72	59 Participants	56 Participants
Proportion of Subjects With a CSFT < 300 μm for the Study Eye by Visit up to Week 76 Week 76	51 Participants	45 Participants

SECONDARY outcome

Timeframe: Week 24 to Week 52 and Week 24 to Week 72

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who were on study treatment until week 52 and until week 72.

Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented

Outcome measures

Measure	Brolucizumab 6 mg n=114 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=115 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 Between Week 24 and Week 52	2.4 Injections Standard Deviation 1.69	2.6 Injections Standard Deviation 2.02
Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 Between Week 24 and Week 72	4.1 Injections Standard Deviation 3.08	4.4 Injections Standard Deviation 3.25

SECONDARY outcome

Timeframe: Week 20 to Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed is the number of subjects from the FAS who did not discontinue from study treatment on or before Week 20.

Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76.

For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1).

Outcome measures

Measure	Brolucizumab 6 mg n=160 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=163 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Time to Recurrence After Week 20 and up to Week 76	12.1 Weeks Interval 12.1 to 12.4	12.1 Weeks Interval 11.4 to 13.4

SECONDARY outcome

Timeframe: Baseline to Week 76

Population: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection.

Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Ocular AEs up to week 52	105 Participants	77 Participants
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Ocular AEs up to week 76	111 Participants	89 Participants
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Non-Ocular AEs up to week 76	119 Participants	117 Participants
Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 Non-Ocular AEs up to week 52	103 Participants	107 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 52 and Week 76

Population: FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had NEI VFQ-25 assessment on scheduled visits.

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL).

The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life.

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg n=246 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 Week 52	6.0 Score on a scale Standard Deviation 14.83	9.0 Score on a scale Standard Deviation 11.10
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 Week 24	5.3 Score on a scale Standard Deviation 13.08	7.4 Score on a scale Standard Deviation 12.46
Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 Week 76	7.4 Score on a scale Standard Deviation 14.44	9.4 Score on a scale Standard Deviation 11.66

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76

Population: SAF-observed: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection with brolucizumab. The number analyzed is the number of subjects from the SAF who had a value for ADA status on scheduled visits.

Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.

Outcome measures

Measure	Brolucizumab 6 mg n=247 Participants 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · Negative	105 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 40	23 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 120	35 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 360	34 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 3240	13 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 9720	4 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 360	21 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 1080	15 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 3240	8 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 9720	3 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 360	16 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 1080	14 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 3240	9 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 1080	29 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Baseline · 29200	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · Negative	101 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 40	26 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 120	30 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 360	35 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 1080	21 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 3240	8 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 9720	5 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 4 · 29200	0 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · Negative	77 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 40	15 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 120	38 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 360	28 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 1080	12 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 3240	14 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 9720	3 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 12 · 29200	0 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · Negative	51 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 40	16 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 120	32 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 24 · 29200	0 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · Negative	35 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 40	8 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 120	20 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 360	28 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 1080	11 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 3240	9 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 9720	3 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 36 · 29200	0 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · Negative	37 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 40	15 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 120	22 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 9720	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 52 · 29200	0 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · Negative	25 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 40	8 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 120	14 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 360	7 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 1080	7 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 3240	5 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 9720	1 Participants	—
Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 Week 76 · 29200	0 Participants	—

Adverse Events

Brolucizumab 6mg

Serious events: 36 serious events

Other events: 104 other events

Deaths: 2 deaths

Aflibercept 2mg

Serious events: 19 serious events

Other events: 87 other events

Deaths: 1 deaths

Overall

Serious events: 55 serious events

Other events: 191 other events

Deaths: 3 deaths

Serious adverse events

Measure	Brolucizumab 6mg n=247 participants at risk 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2mg n=246 participants at risk 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Overall n=493 participants at risk Overall
Infections and infestations Subcutaneous abscess	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Urosepsis	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Staphylococcal sepsis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Vestibular neuronitis	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Endophthalmitis - Study eye	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Gastroenteritis viral	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Pneumonia	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Renal cyst infection	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Cardiac failure congestive	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Hypertensive heart disease	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Cardiac disorders Myocardial infarction	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 2/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Ear and labyrinth disorders Sudden hearing loss	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Endocrine disorders Adrenal mass	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Cataract - Fellow eye	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Cataract - Study eye	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Epiretinal membrane - Fellow eye	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Ocular hypertension - Study eye	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal artery occlusion - Study eye	0.81% 2/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 2/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal ischaemia - Study eye	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal vasculitis - Study eye	0.81% 2/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 2/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal vein occlusion - Study eye	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Uveitis - Study eye	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Gastrointestinal disorders Ascites	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations COVID-19	1.6% 4/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.81% 2/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.2% 6/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations COVID-19 pneumonia	0.81% 2/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 2/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Cellulitis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Dacryocystitis - Study eye	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Emphysematous cystitis	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Endocarditis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Femoral neck fracture	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Head injury	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Carotid artery stenosis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Cerebral haemorrhage	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Cerebral infarction	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Cerebrovascular accident	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Hemiparesis	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Syncope	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Transient ischaemic attack	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 2/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Psychiatric disorders Suicidal ideation	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Renal and urinary disorders Diabetic nephropathy	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Aneurysm	0.81% 2/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 2/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Hypertensive crisis	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Peripheral ischaemia	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Varicose vein	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.20% 1/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment

Other adverse events

Measure	Brolucizumab 6mg n=247 participants at risk 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Aflibercept 2mg n=246 participants at risk 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individual flexible treatment (IFT)	Overall n=493 participants at risk Overall
Eye disorders Glaucoma - Fellow eye	2.0% 5/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 5/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 10/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Glaucoma - Study eye	2.0% 5/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 5/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 10/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Macular oedema - Study eye	7.3% 18/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.5% 11/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.9% 29/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Cataract - Study eye	3.2% 8/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.6% 4/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 12/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Conjunctival haemorrhage - Study eye	6.5% 16/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.5% 11/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.5% 27/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Dry eye - Fellow eye	2.0% 5/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 5/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 10/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Dry eye - Study eye	2.4% 6/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 6/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 12/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Eye pain - Study eye	3.6% 9/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 6/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.0% 15/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Ocular hypertension - Study eye	2.4% 6/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.2% 3/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.8% 9/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal ischaemia - Study eye	2.4% 6/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.4% 7/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Retinal vein occlusion - Study eye	2.8% 7/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.41% 1/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.6% 8/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Uveitis - Study eye	3.2% 8/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	0.00% 0/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.6% 8/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Visual acuity reduced - Study eye	8.9% 22/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.7% 9/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	6.3% 31/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous detachment - Study eye	4.5% 11/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.5% 11/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.5% 22/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Eye disorders Vitreous floaters - Study eye	2.0% 5/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.5% 11/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.2% 16/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations COVID-19	2.0% 5/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 6/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 11/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Nasopharyngitis	3.2% 8/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.4% 6/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.8% 14/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Tooth abscess	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 5/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.2% 6/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Infections and infestations Urinary tract infection	2.8% 7/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.2% 3/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 10/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Investigations Intraocular pressure increased - Study eye	4.0% 10/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.3% 13/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.7% 23/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 9/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.8% 7/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.2% 16/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Musculoskeletal and connective tissue disorders Back pain	0.40% 1/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.0% 5/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	1.2% 6/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Nervous system disorders Headache	1.2% 3/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	3.3% 8/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	2.2% 11/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment
Vascular disorders Hypertension	7.7% 19/247 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	4.1% 10/246 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment	5.9% 29/493 • Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER