Safety and effectiveness of brolucizumab in patients with neovascular age-related macular degeneration: A phase IV study from India.

Abstract

Purpose: The purpose of this study is to evaluate the safety and effectiveness of brolucizumab intravitreal injections (IVI) in Indian patients with neovascular age-related macular degeneration (nAMD).

Methods: This prospective, interventional, single-arm, open-label phase IV study included 105 treatment-naïve nAMD patients prescribed brolucizumab as per the local prescribing information, across ten centers. The treatment period consisted of 56 weeks, including loading doses at Weeks 0, 4, and 8, followed by disease activity assessment at Week 16, evaluating patients for 12-weekly (q12w) or 8-weekly (q8w) dosing. The primary endpoint was the incidence and characteristics of treatment-emergent adverse events (TEAEs) during 56 weeks. Secondary endpoints included changes in effectiveness variables - visual acuity, intraretinal fluid (IRF), subretinal fluid (SRF), and central subfield thickness (CST), at 16 and 56 weeks.

Results: Post-Week 16, 74 (70.5%) patients received q12w, and 27 (25.7%) patients received q8w dosing. Four TEAEs were reported in three (2.9%) patients, all ocular: vitritis in two patients who were discontinued and retinal vasculitis and uveitis in one patient who completed the study. No TEAEs were severe, and there were no serious adverse events. Best corrected visual acuity (BCVA) improved significantly by seven letters (95% CI: 5.0, 10.0) at Week 16 and by 15 letters (95% CI: 10.0, 18.0) at Week 56 (P < 0.0001 for both). All anatomical parameters also showed significant reductions over the study period.

Conclusions: Brolucizumab 6 mg IVI, given as per the prescribing information, demonstrated a positive benefit/risk profile in Indian patients with nAMD, with no new safety signals.