Efficacy and Safety of Brolucizumab in Neovascular Age‑Related Macular Degeneration: A Real-World Study

Abstract

INTRODUCTION: Brolucizumab (Beovu®) is an anti-vascular endothelial growth factor (anti-VEGF) agent approved by the European Medicines Agency (EMA) in 2020 for the treatment of neovascular age-related macular degeneration (nvAMD) and in 2022 for diabetic macular edema. In randomized clinical trials for nvAMD (HAWK and HARRIER), brolucizumab demonstrated visual acuity improvements comparable to aflibercept, with the potential for longer durability. However, post-marketing data raised safety concerns. This study aims to evaluate the real-world safety and efficacy of brolucizumab for nvAMD, focusing on functional and anatomical outcomes, injection intervals, and adverse events.
METHODS: This retrospective study included 42 eyes with nvAMD treated with brolucizumab at Hospital de Braga (2022-2023) that had evaluation with optical coherence tomography (OCT) before and after at least one brolucizumab injection. Outcomes assessed included corrected distance visual acuity (CDVA), central retinal thickness (CRT), macular volume (MV), presence of intraretinal fluid (IRF), subretinal fluid (SRF), serous pigment epithelial detachment (sPED), treatment intervals, and adverse events.
RESULTS: Forty-two eyes from 38 patients (71.1% female, mean age 78±8 years, 57.1% phakic) were included. Most eyes (95.2%) had prior anti-VEGF treatment. CDVA did not significantly change (0.66±0.54 to 0.61±0.46 logMAR, p=0.251), though improvements were seen in the 2 treatment-naïve eyes (25 ETDRS letters in both). Significant improvements were found in CRT (335.6±94.7µm to 301.2±92.1µm, p=0.005) and MV (8.36±1.08 mm³ to 7.98±0.87 mm³, p=0.003). The proportion of eyes with IRF decreased from 42.9% to 23.8% (p=0.021), SRF from 69% to 28.6% (p<0.001), and sPED from 33.3% to 19% (p=0.031). The average treatment interval extended from 6.08±2.47 to 8.00±2.71 weeks (p=0.004). Intraocular inflammation occurred in 7.14% of eyes (n=3), with no retinal vasculitis or vascular occlusion.
CONCLUSION: Brolucizumab demonstrated effectiveness in maintaining CDVA and improving anatomical outcomes, with longer treatment intervals, reducing the treatment burden. The incidence of intraocular inflammation was higher than in trials but in accordance with other real-world studies, emphasizing the need for careful patient selection and close monitoring of adverse events.