• EYDENZELT^® is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR)
• Celltrion plans to enter the U.S. ophthalmology market to meet diverse needs of patients suffering from various eye conditions

 Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT^® (aflibercept-boav), biosimilar referencing 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).^[1]

Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved 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 approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomized, double-masked, parallel-group, multicenter phase III study of EYDENZELT, the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT was compared to EYLEA in patients with diabetic macular edema (DME). The 52-week trial included 348 patients with DME. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing EYDENZELT and EYLEA. Results of the study showed that EYDENZELT met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to EYLEA.

"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."

EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology. EYDENZELT was also approved by the European Commission (EC) in February 2025.