Table 2

Overall and ocular safety data of Japanese participants with PCV

Adverse eventBrolucizumab 6 mg (n=39)Aflibercept 2 mg (n=30)
Participants with ≥1 adverse event, n (%)*
 Ocular (study eye)22 (56.4)12 (40.0)
 Nonocular34 (87.2)24 (80.0)
Participants with ≥1 serious adverse event, n (%)*
 Ocular (study eye)1 (2.6)1 (3.3)
 Nonocular7 (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 event22 (56.4)12 (40.0)
 Cataract5 (12.8)1 (3.3)
 Intraocular pressure increased4 (10.3)2 (6.7)
 Conjunctival haemorrhage3 (7.7)2 (6.7)
 Eye pain3 (7.7)1 (3.3)
 Conjunctivitis3 (7.7)0 (0.0)
 Dry eye2 (5.1)1 (3.3)
 Retinal haemorrhage2 (5.1)1 (3.3)
 Retinal tear2 (5.1)0 (0.0)
 Vitreous detachment1 (2.6)0 (0.0)
 Trichiasis1 (2.6)0 (0.0)
 Conjunctivitis allergic0 (0.0)3 (10.0)
 Glaucoma0 (0.0)0 (0.0)
Intraocular inflammation, retinal arterial occlusive event and endophthalmitis AEs, n (%)†*
 Uveitis2 (5.1)0 (0.0)
 Iritis2 (5.1)0 (0.0)
 Anterior chamber inflammation1 (2.6)0 (0.0)
 Retinal artery occlusion1 (2.6)0 (0.0)
 Retinal perivascular sheathing1 (2.6)0 (0.0)
 Endophthalmitis0 (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.