Celltrion has received approval from the US Food and Drug Administration (FDA) for the biosimilar product, Eydenzelt (aflibercept-boav), to treat several eye conditions.
Eydenzelt is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea (aflibercept), which is jointly developed by Regeneron Pharmaceuticals and Bayer.
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The therapy, administered via injection into the eye, works by blocking the formation of new blood vessels and reducing fluid permeability in ocular blood vessels.
It is indicated for neovascular (wet) age-related macular degeneration, diabetic macular oedema, macular oedema following retinal vein occlusion and diabetic retinopathy.
Eydenzelt is Celltrion’s first biologic product approved by the FDA for use in ophthalmology. It was approved by the European Commission (EC) in February 2025.
Celltrion USA senior vice-president and chief medical officer Dr Juby Jacob-Nara stated: “Timely access to effective therapies is essential for individuals affected by retinal diseases.
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By GlobalData“We are proud to have Eydenzelt approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the US.
“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.”
The FDA decision was supported by a comprehensive review of analytical, nonclinical and clinical data.
A Phase III clinical trial evaluated the safety, efficacy, pharmacokinetics and immunogenicity of Eydenzelt in comparison to Eylea, for 52 weeks.
This multicentre study involved 348 participants with diabetic macular oedema.
The primary endpoint assessed the change in best corrected visual acuity at week 8. Results indicated that Eydenzelt met the predefined equivalence criteria.
Secondary endpoints of safety, efficacy and immunogenicity also showed trends that were consistent with those of Eylea.
In early 2025, Celltrion secured marketing authorisation from the EC for Avtozma, a biosimilar to Chugai’s RoActemra (tocilizumab).
