Celltrion, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar to EYLEA®, for the treatment of several major retinal conditions, including neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
Aflibercept is a VEGF inhibitor used in ophthalmology to block the growth of abnormal blood vessels in the eye and reduce fluid leakage by targeting VEGF-A and placental growth factor (PlGF), key drivers of ocular angiogenesis.
“Timely access to effective therapies is essential for individuals affected by retinal diseases,” 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 marks a significant milestone in the treatment landscape—helping physicians expand their options and improve patient outcomes.”
The FDA approval is supported by a comprehensive set of analytical, nonclinical, and clinical data. Key findings came from a Phase III, double-masked, multicenter trial involving 348 patients with diabetic macular edema. The study compared EYDENZELT with EYLEA, measuring changes in best corrected visual acuity at eight weeks. EYDENZELT met the trial’s predefined equivalence criteria, with secondary outcomes on efficacy, safety, pharmacokinetics, and immunogenicity also aligning closely with those of the reference product.
Dr. David M. Brown, Director at Retina Consultants of Texas Research Centers, emphasized the significance of this approval: “Advanced age-related macular degeneration is one of the leading causes of irreversible blindness, and nearly 20 million Americans are living with some form of it. EYDENZELT will be an important new option for patients with serious retinal diseases.”
EYDENZELT is Celltrion’s first FDA-approved ophthalmology product, following its earlier European Commission (EC) approval in February 2025. With this milestone, Celltrion continues to expand its global footprint in biologic therapies and biosimilars.