Comparative Analysis of Ocular Adverse Events between Aflibercept 8 mg and Faricimab

To compare the ocular safety of intravitreal aflibercept injections and faricimab using population-based, global postmarketing data in a large pharmacovigilance study. Population-based, retrospective pharmacovigilance study. Patients for whom ocular adverse event (AE) reports were submitted to the U.S. FDA Adverse Event Reporting System (FAERS) between January 2004-June 2025, and for whom intravitreal aflibercept injections (2 mg or 8 mg, where dose was recorded) or faricimab were listed as the primary suspect drug, were included. After deduplication, disproportionality was assessed using reporting odds ratios (RORs, 95%CI). Safety signals were considered statistically significant if they met Evans’ criteria (ROR>2, χ 2 >4, n≥3), Bonferroni-adjusted p<0.0003, and Bayesian threshold IC 025 >0. Disproportionality signals for ocular adverse events associated with intravitreal aflibercept 2 mg, aflibercept 8 mg, and faricimab, using aflibercept 2 mg as the reference comparator given its longer market availability and well-established safety profile. Among 13,809,873 FAERS reports, 30,761 involved intravitreal aflibercept 2 mg (n=21,058), aflibercept 8 mg (n=727), or faricimab (n=8,976). After deduplication, 8,352 reports remained for aflibercept 2 mg, 327 for aflibercept 8 mg, 4,168 for faricimab, and 13,797,026 for other drugs. Most patients were aged 65–85 years; women comprised 48.6% of the 8 mg group, 39.9% of faricimab, and 20.8% of the 2 mg group. Aflibercept 8 mg showed the highest disproportionality for intraocular inflammation and infection-related events, including anterior chamber flare (ROR=1410.5), vitritis (853.3), retinal vasculitis (352.2), and infectious (1208.3) and sterile endophthalmitis (352.0), as well as blindness (71.1) and reduced visual acuity (74.6). Faricimab had the highest RORs for injection-related inflammatory and hemorrhagic events—hypopyon (112.8), retinal pigment epithelial tear (193.9), choroidal hemorrhage (142.3), and pseudoendophthalmitis (309.9)—while aflibercept 2 mg was more often associated with structural complications, including increased intraocular pressure (187.8), posterior capsule rupture (80.1), vitreous hemorrhage (76.9), and retinal detachment (20.8). All signals met Bonferroni-adjusted significance (p<0.0001) and Bayesian criteria (IC 025 >0). Aflibercept 8 mg showed strong signals for intraocular inflammation, vasculitis, and endophthalmitis, aflibercept 2 mg was linked to structural complications, and faricimab had the highest disproportionality for select immuno-vascular events. These findings delineate agent- and dose-specific safety profiles within a unified comparative framework and reinforce the critical need for ongoing postmarketing surveillance.