REAL-WORLD RETINAL VASCULITIS EVENTS REPORTED WITH FDA-APPROVED INTRAVITREAL ANTI-VEGF AND COMPLEMENT INHIBITOR...

To analyze real-world Food and Drug Administration Adverse Event Reporting System (FAERS) data for retinal vasculitis associated with approved intravitreal (IVT) anti-VEGF agents and complement inhibitors in the United States.

This retrospective study used the publicly available FAERS database to identify serious adverse events related to IVT anti-VEGF and complement inhibitor agents reported between January 2020 and December 2025. Reports for brolucizumab, faricimab, aflibercept, ranibizumab, pegcetacoplan, and avacincaptad pegol were analyzed, with data for aflibercept and ranibizumab also reviewed from 2010 to 2019. Events were filtered to include only those linked exclusively to a single agent. Retinal vasculitis adverse events (RVAEs) were identified using broad search terms related to vasculitis, while vascular occlusions without inflammation were excluded.

FAERS data from January 2010 to December 2025 showed reported RVAEs across all included IVT therapies, with increased reporting after 2019. From January 2020 to December 2025, 554 RVAEs were identified among anti-VEGF reference products and complement inhibitors. Anti-VEGF reference products accounted for 485 reports (87.5%), and complement inhibitors accounted for 69 (12.5%). Brolucizumab accounted for the largest proportion (56.1%; 311/554), followed by faricimab (16.4%; 91/554), pegcetacoplan (11.9%; 66/554), aflibercept 2 mg (8.7%; 48/554), aflibercept 8 mg (4.2%; 23/554), ranibizumab (2.2%; 12/554), and avacincaptad pegol (0.5%; 3/554). Separate biosimilar analysis identified one aflibercept biosimilar RVAE and no ranibizumab biosimilar RVAEs during this updated study period overall.

FAERS reporting identified RVAEs across included IVT therapies, but cannot establish incidence, causality, or comparative risk, underscoring the need for vigilant reporting and ongoing post-marketing safety surveillance.