FDA accepts BLA for aflibercept 8mg with priority review

Regeneron announced that the FDA has accepted for priority review its BLA for aflibercept 8mg for treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.  The BLA was supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks.  The FDA target action date is 27 June 2023. Aflibercept 8mg is being jointly developed by Regeneron and Bayer A.G.