9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.

The FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomised, double-masked, parallel-group, multi-centre Phase 3 study of Eydenzelt, the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt was compared to Eylea in patients with diabetic macular oedema.

Read Celltrion press release