Celltrion said Friday that the U.S. FDA approved Eydenzelt (CT-P42), an ophthalmology biosimilar to Regeneron’s Eylea (aflibercept). The decision covers both vial and prefilled-syringe versions.

In a phase 3 trial of 348 patients with diabetic macular edema, Eydenzelt matched the reference drug in efficacy and safety. On those data, the FDA cleared all adult indications held by Eylea in the United States: wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Eylea generated $9.52 billion in global sales in 2024, including $5.97 billion in the U.S. The approval adds another major market for Eydenzelt, which is already authorized in Korea, Europe and Australia, and advances Celltrion’s push into eye-care medicines. 

With Eydenzelt (aflibercept), Celltrion’s U.S. lineup now includes 11 biologics, among them the autoimmune therapy Avtozma (adalimumab), bone-disease biosimilar Stoboclo-Osenvelt (denosumab), and allergy treatment Omlyclo (omalizumab).