Efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy in Japanese participants of HAWK. Issue 7 (22nd July 2021)

• Record Type: Journal Article
• Authors: Ogura, Yuichiro; Jaffe, Glenn J; Cheung, Chui Ming Gemmy; Kokame, Gregg T; Iida, Tomohiro; Takahashi, Kanji; Lee, Won Ki; Chang, Andrew A; Monés, Jordi; D'Souza, Divya; Weissgerber, Georges; Gedif, Kinfemichael; Koh, Adrian
• Is Part Of: British journal of ophthalmology. Volume 106:Issue 7(2022)
• Page Start: 994
• Page End: 999
• Publication Date: 2021-07-22
• Subjects: clinical trial -- retina; Ophthalmology -- Periodicals; 617.7
• DOI: 10.1136/bjophthalmol-2021-319090
• Languages: English
• ISSNs: 0007-1161

Abstract

Abstract : Purpose: To compare the efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy (PCV) over 96 weeks in the HAWK study. Design: HAWK was a global, 2-year, randomised, double-masked, multicentre phase III trial in participants with neovascular age-related macular degeneration. Methods: Of the Japanese participants with PCV, 39 received brolucizumab 6 mg and 30 received aflibercept 2 mg. After 3 monthly loading doses, brolucizumab-treated eyes received an injection every 12 weeks (q12w) but were adjusted to q8w if disease activity was detected. Aflibercept-treated eyes received fixed q8w dosing. Mean change in best-corrected visual acuity (BCVA), the proportion of participants on q12w, retinal thickness, retinal fluid changes and safety were assessed to Week 96. Results: Mean change in BCVA (early treatment diabetic retinopathy study (ETDRS) letters) from baseline to week 48/week 96 was+10.4/+11.4 for brolucizumab and +11.6/+11.1 for aflibercept. For brolucizumab-treated eyes, the probability of only q12w dosing after loading through week 48 was 76%, and 68% through week 96. Fluid resolution was greater with brolucizumab than aflibercept: respective proportions of eyes with intraretinal fluid and/or subretinal fluid were 7.7% and 30% at week 48% and 12.8% and 16.7% at week 96. Brolucizumab exhibited an overall well-tolerated safety profile despite a higher rate of intraocular inflammation compared with aflibercept. Conclusion: In Japanese eyes with PCV, brolucizumab q12w/q8w monotherapy resulted in robust and consistent BCVA gains that were comparable to q8w aflibercept dosing. Anatomical outcomes favoured brolucizumab over aflibercept, with 76% of brolucizumab participants maintained on q12w dosing after loading to week 48.