| アブストラクト | PURPOSE: To analyze real-world Food and Drug Administration Adverse Event Reporting System (FAERS) data for retinal vasculitis associated with approved intravitreal (IVT) anti-vascular endothelial growth factor (anti-VEGF) agents and complement inhibitors in the United States. METHODS: 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 2010-2019. Events were filtered to include only those linked exclusively to a single agent. RVAEs were identified using broad search terms related to vasculitis, while vascular occlusions without inflammation were excluded. RESULTS: FAERS data from January-2010 to December-2025 showed reported RVAEs across all included intravitreal 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 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. CONCLUSIONS: FAERS reporting identified RVAEs across included intravitreal therapies, but cannot establish incidence, causality, or comparative risk, underscoring the need for vigilant reporting and ongoing post-marketing safety surveillance. |
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