Eydenzelt – a biosimilar referencing Eylea (aflibercept) – has been approved in the United States market for a range of neovascular retinal conditions.
Celltrion has announced that the United States Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), for the treatment of neovascular age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DMO), and diabetic retinopathy (DR).1
“Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have Eydenzelt approved by the FDA,” 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.”
Eydenzelt is Celltrion’s first FDA-approved biologic product in ophthalmology. Eydenzelt was also approved by the European Commission in February 2025. The drug is currently under evaluation by the Therapeutic Goods Administration in Australia for a range of conditions, including nAMD and DMO.2
References
- Celltrion, Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept) (media release, 10 October 2025) available at: celltrion.com/en-us/company/media-center/press-release/4201 [accessed Oct 2025].
- Therapeutic Goods Administration, Eydenzelt Celltrion Healthcare Australia Pty Ltd (webpage) available at: tga.gov.au/resources/prescription-medicines-under-evaluation/eydenzelt-celltrion-healthcare-australia-pty-ltd [accessed Oct 2025].
