Ocular adverse events associated with aflibercept and faricimab: a population-based pharmacovigilance study

Abstract

Objective

To evaluate the postmarketing ocular adverse events (AEs) reported for intravitreal antivascular endothelial growth factor (anti-VEGF) therapies, aflibercept (2 mg and 8 mg), and faricimab (6 mg).

Design

Retrospective pharmacovigilance analysis.

Participants

Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods

We conducted a retrospective pharmacovigilance analysis of the FAERS database from the fourth quarter of 2023 to the first quarter of 2025. Descriptive statistics and reporting odds ratio (ROR) analysis were employed to evaluate and compare AEs between 2 mg aflibercept, 8 mg aflibercept, and faricimab.

Results

A total of 462 unique reports of AEs secondary to 2 mg aflibercept, 151 reports for 8 mg aflibercept, and 2 427 reports for faricimab were identified. Ocular AEs that were disproportionately over-reported for all of the 3 agents included intraocular injection complications, increased intraocular pressure, endophthalmitis, reduced visual acuity, eye inflammation, uveitis, visual impairment, and blurred vision.

Conclusions

In this study, faricimab generally showed lower point estimates for ROR of ocular AEs compared to 2 mg and 8 mg aflibercept; however, the wider confidence intervals for some outcomes reflect the limited number of reports and highlight the need for continued safety monitoring, particularly given the inherent reporting biases and lack of detailed patient or dosing information in the FAERS database.