Brolucizumab clinical and safety outcomes in a neovascular age-related macular degeneration national database: Fight Retinal Blindness Spain (FRB Spain)
- PMID: 40473932
- PMCID: PMC12325991
- DOI: 10.1038/s41433-025-03871-6
Brolucizumab clinical and safety outcomes in a neovascular age-related macular degeneration national database: Fight Retinal Blindness Spain (FRB Spain)
Abstract
Aim: To evaluate clinical outcomes, treatment intervals, and safety outcomes of brolucizumab (BRO) treatment in a national neovascular age-related macular degeneration (nAMD) database.
Methods: Multicentre, national, routine clinical care database study of nAMD eyes receiving ≥1 BRO injection. Demographics, visual acuity (VA) measured in logMAR letters, macular neovascularization (MNV) activity, number of injections, visit data and information on any adverse events were collected at baseline and at 3, 6, 9 and 12 months after BRO initiation for each patient/eye.
Results: A total of 305 eyes received 1 BRO injection and 214 eyes (14% naïve, 86% switchers) completed 3 months follow-up. In switchers, the percentage of eyes extended to ≥8 week intervals at 3/6/9 months was 43.2%/45.7%/54.5% and to ≥10 week intervals was 12.9%/18.5%/13.6%, respectively. Eyes with VA ≥ 70 increased from 36% at baseline to 48% at 3 months and 50% at 9 months. MNV lesion activity status decreased from 94% (active/active-only SRF, 46/48%) at baseline to 56% (21/35%), 61% (23/38%), 76% (27/49%) and 65% (24/41%) at months 3/6/9 and 12, respectively. Adverse effects were observed in 6.5% of the treated eyes, being the most prevalent anterior uveitis (3.2%), vitritis (4.5%) and vasculitis (2.2%).
Conclusion: In this series BRO achieves an extension in the treatment intervals in half of the patients which require frequent reinjections (<8 weekly), reducing MNV activity in a third of this specific difficult-to-treat subgroup. The adverse event rates described are consistent with other cohorts and need to be considered to inform treatment decisions in case-by-case discussions.
© 2025. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.
Conflict of interest statement
Competing interests: Javier Zarranz-Ventura is a grant holder for Novartis Pharmaceuticals, Bayer, Allergan/Abbvie and Roche, and a consultant for Novartis Pharmaceuticals, Bayer, Allergan/Abbvie, Alcon, Alimera Sciences, Bausch and Lomb, Brill Pharma, DORC, Preceyes, Roche, Topcon, and Zeiss.
References
-
- Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;12:772–84. - PubMed
-
- Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, et al. HAWK and HARRIER: ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2021;128:89–99. - PubMed
-
- Bilgic A, Kodjikian L, de Ribot FM, Spitzer MS, Vasavada V, Gonzalez-Cortes JH, et al. Real-world experience with brolucizumab in neovascular age-related macular degeneration over 2 years: the REBA extension study. Graefe’s Arch Clin Exp Ophthalmol. 2024;262:1161–7. - PubMed
-
- Kim DJ, Kim DG, Kwak HD, Jang JY, Ji YS, Lee SH, et al. Long-term efficacy and safety of brolucizumab in neovascular age-related macular degeneration: a multicentre retrospective real-world study. Acta Ophthalmol. 2024;102:e1018–28. - PubMed
-
- Kim DJ, Jin KW, Han JM, Lee SH, Park YS, Lee JY, et al. Short-term safety and efficacy of intravitreal brolucizumab injections for neovascular age-related macular degeneration: a multicenter retrospective real-world study. Ophthalmologica. 2023;246:192–202. - PubMed
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