Overall and ocular safety data of Japanese participants with PCV
| Adverse event | Brolucizumab 6 mg (n=39) | Aflibercept 2 mg (n=30) |
| Participants with ≥1 adverse event, n (%)* | ||
| Ocular (study eye) | 22 (56.4) | 12 (40.0) |
| Nonocular | 34 (87.2) | 24 (80.0) |
| Participants with ≥1 serious adverse event, n (%)* | ||
| Ocular (study eye) | 1 (2.6) | 1 (3.3) |
| Nonocular | 7 (17.9) | 7 (23.3) |
| Participants with ≥15 letter loss from baseline at week 96, n (%)† | 0 (0.0) | 0 (0.0) |
| Participants with ≥1 nonocular arterial thromboembolic event, n (%)* | 0 (0.0) | 0 (0.0) |
| Death, n (%) | 0 (0.0) | 0 (0.0) |
| Ocular AEs (≥5%), preferred term, n (%)† | ||
| Participants with ≥1 event | 22 (56.4) | 12 (40.0) |
| Cataract | 5 (12.8) | 1 (3.3) |
| Intraocular pressure increased | 4 (10.3) | 2 (6.7) |
| Conjunctival haemorrhage | 3 (7.7) | 2 (6.7) |
| Eye pain | 3 (7.7) | 1 (3.3) |
| Conjunctivitis | 3 (7.7) | 0 (0.0) |
| Dry eye | 2 (5.1) | 1 (3.3) |
| Retinal haemorrhage | 2 (5.1) | 1 (3.3) |
| Retinal tear | 2 (5.1) | 0 (0.0) |
| Vitreous detachment | 1 (2.6) | 0 (0.0) |
| Trichiasis | 1 (2.6) | 0 (0.0) |
| Conjunctivitis allergic | 0 (0.0) | 3 (10.0) |
| Glaucoma | 0 (0.0) | 0 (0.0) |
| Intraocular inflammation, retinal arterial occlusive event and endophthalmitis AEs, n (%)†* | ||
| Uveitis | 2 (5.1) | 0 (0.0) |
| Iritis | 2 (5.1) | 0 (0.0) |
| Anterior chamber inflammation | 1 (2.6) | 0 (0.0) |
| Retinal artery occlusion | 1 (2.6) | 0 (0.0) |
| Retinal perivascular sheathing | 1 (2.6) | 0 (0.0) |
| Endophthalmitis | 0 (0.0) | 0 (0.0) |
Medical Dictionary for Regulatory Activities Version 20.1 has been used for the reporting of adverse events. Safety Analysis Set.
*AEs with a start date on or after the date of first study treatment administration were counted. A participant with multiple occurrences of an AE for a preferred term or system organ class was counted only once in each specific category.
†Ocular AEs≥5% in any treatment arm in the study.
‡Selected for incidence >2% in either study and/or clinician interest.
AE, adverse event; PCV, polypoidal choroidal vasculopathy.