Post-marketing data highlight distinct ocular safety signals for GA therapies
A pharmacovigilance analysis of FDA Adverse Event Reporting System (FAERS) data has identified differing safety profiles for pegcetacoplan and avacincaptad pegol, the only approved treatments for geographic atrophy, according to a poster presented at AAO 2025.
The study reviewed adverse event (AE) reports through December 2024, focusing on cases where either drug was the primary suspect. Investigators found 752 AE reports linked to pegcetacoplan and 80 linked to avacincaptad pegol.
Pegcetacoplan was more frequently associated with serious events such as iris hemorrhage, choroidal neovascularization, retinal vasculitis, hemorrhagic occlusive retinal vasculitis, and bacterial endophthalmitis. In contrast, avacincaptad pegol was most often associated with choroidal neovascularization, vitritis, dry AMD, and cystoid macular edema.
The authors noted that pegcetacoplan exhibited a broader range of reported AEs compared with avacincaptad pegol. They emphasized the need for ongoing clinician vigilance and careful monitoring as real-world use of these novel agents expands.
Reference
Kailani Z, et al. Ocular AEs Associated With Pegcetacoplan and Avacincaptad Pegol for GA. Poster presented at: American Academy of Ophthalmology Annual Meeting; October 18–20, 2025; Orlando, FL.