Celltrion Receives FDA Approval for Eylea Biosimilar Eydenzelt

The FDA has approved Celltrion's Eydenzelt (aflibercept-boav), a biosimilar referencing Eylea (aflibercept), for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

The FDA’s decision was supported by a totality of evidence, including analytical, nonclinical, and clinical data confirming Eydenzelt's biosimilarity to Eylea. A randomized, double-masked, parallel-group, multicenter phase 3 study evaluated Eydenzelt in comparison with Eylea in 348 patients with DME over 52 weeks. The study’s primary endpoint—change in best corrected visual acuity (BCVA) from baseline at week 8—met predefined equivalence criteria between the two treatments. Secondary endpoints assessing efficacy, safety, pharmacokinetics, and immunogenicity demonstrated comparable results.

Eydenzelt is Celltrion’s first FDA-approved biologic in ophthalmology, following its European Commission (EC) approval in February 2025.