FDA Approves Celltrion’s Eylea Biosimilar Eydenzelt for Retinal Diseases

The U.S. Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), a biosimilar referencing Eylea (aflibercept), developed by Celltrion. This biosimilar has been authorized for the treatment of multiple retinal conditions, marking a major milestone in Celltrion's entry into the ophthalmology sector.

Indications for Eydenzelt

Eydenzelt is approved for the treatment of several serious retinal conditions, including wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Clinical Evidence Supporting FDA Approval

The FDA's decision was based on a totality of evidence approach, incorporating analytical, nonclinical, and clinical data to confirm biosimilarity to the reference product, Eylea.

A pivotal phase 3 clinical trial, randomized, double-masked, and multicenter, evaluated Eydenzelt in 348 patients with diabetic macular edema (DME) over a 52-week period. The primary endpoint, which assessed the change in best corrected visual acuity (BCVA) from baseline at week 8, met predefined equivalence criteria between Eydenzelt and Eylea.

Additionally, secondary endpoints evaluating efficacy, safety, pharmacokinetics, and immunogenicity demonstrated comparable outcomes between the two treatments, further reinforcing Eydenzelt’s biosimilarity.

A First in Ophthalmology for Celltrion

Eydenzelt is Celltrion’s first FDA-approved biologic in the field of ophthalmology. This U.S. approval follows the biosimilar’s European Commission (EC) approval in February 2025, marking a strategic expansion into global ophthalmic markets.

Leadership Commentary

Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, emphasized the significance of the FDA’s approval:

“Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have EYDENZELT approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the U.S. With EYDENZELT demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases—helping physicians broaden their options and improving patient outcomes.”