Celltrion, Inc’s Eydenzelt (aflibercept-boav) has won US Food and Drug Administration approval 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), the company announced.  

Aflibercept-boav is a biosimilar referencing Eylea (aflibercept; Regeneron). Aflibercept is formulated as an ocular injection that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in ocular angiogenesis. In a randomized, double-masked, parallel-group, multicenter phase 3 study of Eydenzelt, its efficacy, safety, pharmacokinetics, and immunogenicity were 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. Results showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea, according to the company.

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