Increased Risk of Retinal Vasculitis May Be Associated with Aflibercept 8 mg: A Pharmacovigilance Analysis of the FAERS Database.

Abstract

Purpose: To evaluate the risk of retinal vasculitis and related adverse events (AEs) among five commercially available anti-vascular endothelial growth factor (anti-VEGF) agents using data from the FDA Adverse Event Reporting System (FAERS).

Methods: A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2004 to Q4 2024. Adverse drug reactions (ADRs) were categorized using the Medical Dictionary for Regulatory Activities (MedDRA), with "Retinal Vasculitis" as the primary outcome and "Uveitis" and "Vitritis" as secondary outcomes. Disproportionality analysis was performed using ranibizumab as the reference drug. Logistic regression identified associations between demographic factors and ADRs. The analysis included only reports linking a single drug to the ADR and was limited to patients aged ≥18 years.

Results: Out of 49,114 initial reports 45,768 met the inclusion criteria. Retinal vasculitis was reported in 314 cases (0.7%), vitritis in 689 cases (1.5%), and uveitis in 1,344 cases (2.9%). Older age (OR 1.012; p = 0.045) and female sex (OR 1.747; p < 0.001) were significantly associated with retinal vasculitis. All agents showed higher odds of uveitis and retinal vasculitis compared to ranibizumab, with brolucizumab having the highest reporting odds ratio (ROR) for retinal vasculitis (331.61). Aflibercept 8 mg showed a significantly higher ROR (62.8) for retinal vasculitis compared to the 2 mg dose (3.82).

Conclusions: This study identified a safety signal indicating a possible increased risk of retinal vasculitis with aflibercept 8 mg compared to the conventional 2 mg dose. This finding requires confirmation through future postmarketing studies.