EYDENZELT, Celltrion’s biosimilar referencing EYLEA, approved by FDA

The US Food and Drug Administration (FDA) has approved Celltrion’s aflibercept-boav (EYDENZELT) biosimilar referencing aflibercept (EYLEA) for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).¹

EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology. It was also approved by the European Commission in February 2025.²

Juby Jacob-Nara, MD, senior vice president and CMO at Celltrion, commented on the approval in a press release from the company, saying, "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 US. 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."

The FDA approval was based on a “totality of evidence including analytical, nonclinical, and clinical data,” according to the company. Included are the recently announced 52-week findings from its global phase 3 clinical trial.³

A total of 348 enrolled patients with DME were included in the randomized, double-masked, parallel-group, multi-center phase 3 trial for the evaluation of EYDENZELT’s therapeutic equivalence, sustained efficacy, and safety when compared to EYLEA.

According to the company, study findings demonstrated both treatment groups had progressive improvement in best-corrected visual acuity (BCVA) from baseline to week 16 and saw stable levels maintained through week 52. The company also noted no significant difference observed between the 2 groups in secondary endpoints, such as average change in central retinal thickness or overall safety outcomes.³

David M Brown, MD, director at Retina Consultants of Texas Research Centers and co-chair of the Medical Leadership Board of Retina Consultants of America, commented, "EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases."

References:

1. Celltrion receives U.S. FDA approval for EYDENZELT (aflibercept-boav), biosimilar referencing EYLEA (aflibercept). Published October 9, 2025. Accessed October 10, 2025. https://www.prnewswire.com/news-releases/celltrion-receives-us-fda-approval-for-eydenzelt-aflibercept-boav-biosimilar-referencing-eylea-aflibercept-302580323.html

2. Hattie H. CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars. Published February 3, 2025. Accessed October 10, 2025. https://www.ophthalmologytimes.com/view/chmp-of-the-european-medicines-agency-issues-positive-opinion-on-2-aflibercept-biosimilars

3. Filkins K. Celltrion announces phase 3 trial data for EYDENZELT. Published September 7, 2025. Accessed October 10, 2025. https://www.ophthalmologytimes.com/view/celltrion-announces-phase-3-trial-data-for-eydenzelt