Efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy in Japanese participants of HAWK.

To compare the efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy (PCV) over 96 weeks in the HAWK study. HAWK was a global, 2-year, randomised, double-masked, multicentre phase III trial in participants with neovascular age-related macular degeneration. 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. 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. 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.

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Competing interests: Glenn Jaffe and Jordi Mones are members of the Brolucizumab Safety Review Committee. Y. Ogura: Consultant for Novartis, Bayer Holding, Alcon Japan, Wakamoto Pharmaceuticals, HOYA Corporation, Astellas Pharma, Senju Pharmaceutical, Boehringer Ingelheim, Chengdu Kanghong Biotechnology, Kyoto Drug Discovery & Development; Lecture fees—Santen Pharmaceuticals, KOWA, Novartis, Bayer Holding, TOPCON, NIKON Healthcare Japan, Sanwa KagakuG. J. Jaffe: Consultant for Novartis, Eyepoint, Iveric, Neurotech, RegeneronG. Cheung: Consultant for Novartis, Bayer, Roche, Boehringer-Ingelheim, Topcon, Samsung; Lecture fees - Topcon, Novartis, Bayer; Grant—ZeissG. T. Kokame: Consultant for Regeneron, Bayer, Genentech, Bausch and Lomb, Santen, Iveric, Allergan Zeiss; Speaker for Regeneron, Bayer, Second Sight, Bausch & Lomb, Salutaris Medical Devices, Zeiss; Research Support from Genentech, Regeneron, Salutaris Medical DevicesT. Iida: Consultant for Novartis, Bayer Healthcare Pharmaceuticals, Tyugai; Lecture fees and grant support—Nidek, Inc., Santen, Inc., Senju Pharmaceutical Co., Ltd, Alcon Laboratories, Inc, Novartis, Bayer Healthcare Pharmaceuticals; Grant support; Topcon Medical Systems Inc. K. Takahashi: Consultant for Novartis, Bayer, Kyowa Kirin, Santen, Allergan Japan, Lecture fees from Novartis, Bayer, Santen, SenjyuW. K. Lee: Consultant for Novartis, Bayer, Allergan, Santen, Boehringer-Ingelheim, Roche; Lecture fee from Novartis, Bayer, AllerganA. Chang: Consultant for Novartis, Bayer, Allergan, Roche, AlconJ. Monés: Consultant/Advisor for Novartis, Alcon, Bayer, Iveric Bio, Notal Vision, Roche, Cellcure, Lineage and Reneuron; Financial Interests: Iveric Bio, Notal Vision; Lecture Fees from Novartis, Roche and Ophthotech; Trial grants from Novartis, Bayer, Roche and IvericD. D’Souza, G. Weissgerber, K. Gedif: Employees of Novartis Pharma AGA. Koh: Consultant for Novartis, Bayer, Allergan, Carl Zeiss Meditec, and Heidelberg Engineering.