South Korean biopharmaceutical company Celltrion Inc announced on Thursday that the US Food and Drug Administration (FDA) has approved EYDENZELT (aflibercept-boav), its biosimilar referencing EYLEA (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Aflibercept is a VEGF inhibitor formulated as an injection for the eye that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in ocular angiogenesis.

According to Celltrion, the FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical data. In a randomised, double-masked, parallel-group, multicentre phase III study of EYDENZELT, the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT was compared to EYLEA in patients with DME. The 52-week trial included 348 patients with DME. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing EYDENZELT and EYLEA. The study results showed that EYDENZELT met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to EYLEA.

EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology. It was approved by the European Commission in February 2025.