Temporal, Phenotypic, and Treatment-Context Heterogeneity in Retinal Vasculitis Reporting with Pegcetacoplan: A United States Pharmacovigilance Study

Background/Objectives: Pegcetacoplan slows geographic atrophy (GA) progression, but postmarketing retinal vasculitis remains an important safety concern. We evaluated whether retinal vasculitis reporting changed over time, whether the reported phenotype changed with respect to occlusive coding, and whether vasculitis was associated with identifiable treatment contexts.

Methods

We analyzed the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) data from 17 February 2023 through 31 December 2025. Strict retinal vasculitis reports required pegcetacoplan to be coded as the primary-suspect drug. Faricimab was used as a descriptive contemporaneous intravitreal comparator because US exposure estimates could be constructed over the same period; it was not treated as a safety-neutral control. Separately, within all US primary-suspect Syfovre reports, we examined whether another anti-vascular endothelial growth factor (anti-VEGF) agent was co-reported. These anti-VEGF agents were evaluated as treatment-context variables rather than as temporal comparators.