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FDA Approves Celltrion's EYDENZELT, Biosimilar To EYLEA, For Multiple Retinal Conditions

October 09, 2025 — 09:38 pm EDT

Written by RTTNews.com for RTTNews

(RTTNews) - Celltrion Inc. announced that the U.S. Food and Drug Administration 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).

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

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