Celltrion’s biosimilar, Eydenzelt (aflibercept-boav), has been approved by the FDA as a treatment for adult patients with neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR), according to a company news release .
Eydenzelt is a biosimilar of Eylea (aflibercept). There are currently five other Eylea biosimilars:
Opuviz : (aflibercept-yszy)
Yesafili : (aflibercept-jbvf)
Ahzantive : (aflibercept-mrbb)
Enzeevu : (aflibercept-abzv)
Pavblu : (aflibercept-ayyh)
This FDA approval was made using the results of the phase 3, 52-week trial that included 348 patients with DME. The primary endpoint was progressive improvement best-corrected visual acuity measured at