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

Abstract

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

One-year outcomes of intravitreal brolucizumab injections in patients with polypoidal choroidal vasculopathy

“…In the current study, two (11.8%) of 17 eyes had IOI. The frequency of IOI was roughly the same compared with a sub-analysis of HAWK study which Ogura et al reported (15.4%) 15 – 17 . Although IVBr injections for PCV are effective, we should be cautious about IOI and treat promptly if brolucizumab-related IOI develops.…”

“…In a sub-analysis of the HAWK study, Ogura et al 17 reported the efficacy of brolucizumab in Japanese patients with PCV. They reported brolucizumab (n = 39) was as good as aflibercept (n = 30) in improving vision.…”

“…A dry macula was achieved in 73.3% after 1 year. Ogura et al 17 reported the efficacy of brolucizumab in Japanese patients with PCV in a sub-analysis of the HAWK study. The authors reported that the probability of 12-week-interval injections after a loading phase through 48 weeks was 76%, which was similar to our result.…”

Brolucizumab: Evaluation of Compassionate Use of a Complex Anti-VEGF Therapy

“…After three monthly loading IVI of both brolucizumab 6mg/0.05mL dosed at 8 or 12 weeks and aflibercept 2mg/0.05mL dosed at 8 weeks, two separate Phase III clinical trials [HAWK (NCT02307682) and HARRIER (NCT02434328)] showed that brolucizumab was non-inferior to the comparative agent in terms of visual acuity for treatment-naïve neovascular age-related macular degeneration (AMD). [4][5][6][7] Brolucizumab has a potential for increased durability and is the first drug in its class to be authorized for, after three loading doses, a dosing interval range of 8 to 12 weeks. 6 This agent was granted approval on October 7, 2019, in the United States (US) by the Food and Drug Administration; following this, it gained approval for use in the European Union (EU) on February 17, 2020, by the European Commission.…”

“…[4][5][6][7] Brolucizumab has a potential for increased durability and is the first drug in its class to be authorized for, after three loading doses, a dosing interval range of 8 to 12 weeks. 6 This agent was granted approval on October 7, 2019, in the United States (US) by the Food and Drug Administration; following this, it gained approval for use in the European Union (EU) on February 17, 2020, by the European Commission. 8 Using HAWK and HARRIER along with additional supportive safety data, provided by a Phase I (NCT01304693) and Phase II study (OSPREY; NCT01796964), brolucizumab underwent a systemic and ocular safety assessment.…”