The FDA approved Celltrion’s EYDENZELT, a biosimilar to EYLEA, for treating multiple eye conditions, expanding treatment access.

The U.S. FDA has approved Celltrion’s EYDENZELT (aflibercept-boav), a biosimilar to EYLEA, for treating wet age-related macular degeneration, diabetic macular edema, macular edema from retinal vein occlusion, and diabetic retinopathy. The approval, based on clinical and analytical data including a phase III trial with 348 DME patients, confirms EYDENZELT’s equivalent efficacy, safety, and pharmacokinetics to EYLEA. It is available as an injection and prefilled syringe, marking Celltrion’s first FDA-approved ophthalmology product and expanding treatment access in a $9.5 billion market. The drug was previously approved in Europe and Australia, with Celltrion aiming to commercialize 22 biosimilars by 2030.