Celltrion, Inc. said the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar of EYLEA® (aflibercept), for several retinal conditions. These include neovascular (wet) age-related macular degeneration (wAMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
Aflibercept is a VEGF inhibitor given as an injection for the eye. It works by stopping the growth of new blood vessels and limiting fluid passage through blood vessels in the eye, targeting VEGF-A and placental growth factor (PlGF), which are key factors in ocular angiogenesis.
“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.,” said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA. “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’s decision to approve EYDENZELT for retinal diseases was informed by a comprehensive evaluation of analytical, nonclinical, and clinical evidence. A pivotal phase III study, randomized, double-masked, and multicenter in design, compared EYDENZELT with EYLEA in 348 patients diagnosed with diabetic macular edema over a 52-week period. The primary endpoint measured the change in best-corrected visual acuity at week 8 from baseline. EYDENZELT met all predefined equivalence criteria, with secondary assessments of efficacy, safety, and immunogenicity showing comparable trends to the reference product.
“Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world and nearly 20 million people in the U.S. are living with some form of age-related macular degeneration,” said Dr. David M. Brown, Director, Retina Consultants of Texas Research Centers, Co-chair, Medical Leadership Board Retina Consultants of America. “EYDENZELT will be an important new addition to our options for the treatment of our patients with serious retinal diseases.”
Approval granted to EYDENZELT for retinal diseases represents Celltrion’s first FDA-approved biologic in ophthalmology. The therapy had previously received authorization from the European Commission (EC) in February 2025.
