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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 \(\ge \)1 BRO injection and 214 eyes (14% naïve, 86% switchers) completed \(\ge \)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.

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Fig. 1: Visual outcomes, lesion activity and treatment intervals in Brolucizumab treated eyes included in the study.

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Acknowledgements

The authors would like to thank Sonia de Orte Seemann and Cristina Martinez García from Syneos Health for their invaluable help in the overall management of this study; Guillem Masdeu, Miguel Moratalla, Judith Martinez, Daniel Garcés, Maria Jose Gonzalez and Antonia Soriano from Fundació Clínic per a la Recerca Biomedica (FCRB-IDIBAPS) for the administrative support with contracts and legal issues; and Laia Gomez-Baldo and Carmen Navarro from Novartis Spain for the external support during the development of this study.

Funding

This work was supported in part by an independent research collaboration from Novartis Pharmaceuticals. No member of Novartis participated in the analysis of the presented data.

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Conception and design, obtained funding and overall responsibility: JZV; data collection: JZV, SMP, MFB, BPM, EC, CARF, CB, APC, IAV, CB, ECi, JAC, FJAP, PC, MPRT, MFR, and CBM; analysis, interpretation and writing: JZV, SMP, RMP, and CBM; manuscript revision: JZV, SMP, RMP, MFB, BPM, EC, CARF, APC, IAV, CB, ECi, JAC, FJAP, PC, MPRT, GSG, MFR, RPCM, and CBM.

Corresponding author

Correspondence to Javier Zarranz-Ventura.

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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.

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Zarranz-Ventura, J., Marías-Pérez, S., Martin-Pinardel, R. et al. Brolucizumab clinical and safety outcomes in a neovascular age-related macular degeneration national database: Fight Retinal Blindness Spain (FRB Spain). Eye 39, 2407–2414 (2025). https://doi.org/10.1038/s41433-025-03871-6

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