Celltrion has received approval from the US Food and Drug Administration (FDA) for EYDENZELT (aflibercept-boav), a biosimilar to EYLEA (aflibercept), 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).

Aflibercept, a VEGF inhibitor administered via intravitreal injection, works by blocking VEGF-A and placental growth factor (PlGF)—two key proteins involved in ocular angiogenesis.

"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,” Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA.  

The FDA’s approval was supported by comprehensive analytical, nonclinical, and clinical data. Results from a phase III clinical trial showed that EYDENZELT met predefined equivalence criteria compared to EYLEA, with similar outcomes across secondary endpoints, including efficacy, safety, and immunogenicity.  

"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 US 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,” he added.  

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