There is a potential increased risk of retinal vasculitis with aflibercept 8 mg compared to the 2 mg dose, according to a study that highlight the need for further postmarketing studies to confirm the safety of higher-dose anti-VEGF treatments.
Researchers conducted a retrospective analysis of FDA Adverse Event Reporting System (FAERS) reports from 2004 to 2024, focusing on cases of retinal vasculitis, uveitis, and vitritis for 5 commercially available anti-VEGF agents. Among 45,768 eligible reports, retinal vasculitis was identified in 314 cases (0.7%), uveitis in 1,344 cases (2.9%), and vitritis in 689 cases (1.5%). Older age and female sex were significantly associated with retinal vasculitis.
Compared to ranibizumab, all anti-VEGF agents showed increased odds of uveitis and retinal vasculitis, with brolucizumab having the highest reporting odds ratio (ROR) for retinal vasculitis (331.61). Aflibercept 8 mg had a markedly higher ROR (62.8) compared to the 2 mg dose (3.82), suggesting a potential increased risk of retinal vasculitis with higher dose aflibercept.
Reference
Nowroozzadeh MH, Hajipourkhorasani M. Increased Risk of Retinal Vasculitis May Be Associated with Aflibercept 8 mg: A Pharmacovigilance Analysis of the FAERS Database. Ocul Immunol Inflamm. 2025;1-3. doi: 10.1080/09273948.2025.2476061. Epub ahead of print. PMID: 40048264.
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