The U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar referencing EYLEA® (aflibercept), for the treatment of several serious retinal conditions, including neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR), as announced by Celltrion, Inc. This approval marks Celltrion’s entry into the U.S. ophthalmology market with its first FDA-approved biologic product in this therapeutic area. This approval marks Celltrion’s entry into the U.S. ophthalmology market with its first FDA-approved biologic product in this therapeutic area.

As an anti-VEGF inhibitor, EYDENZELT is formulated as an injection for the eye, working to block the growth factors VEGF-A and PlGF to inhibit the growth of new, leaky blood vessels and decrease vascular permeability in the eye.

The FDA’s decision was based on a comprehensive set of data, including a 52-week, multi-center Phase III study in patients with DME that successfully demonstrated biosimilarity and therapeutic equivalence to the reference product, EYLEA, across primary and secondary endpoints including best corrected visual acuity, efficacy, safety, pharmacokinetics, and immunogenicity.

Experts in the field view the availability of EYDENZELT as a significant development, particularly for patients with conditions like advanced AMD, a leading cause of irreversible blindness, as it provides physicians with an important new option for treating serious retinal diseases and improving patient access to effective therapies. The drug, which was also approved by the European Commission in February 2025, is contraindicated in patients with active ocular infections or inflammation and carries warnings regarding the potential for increased intraocular pressure and a risk of arterial thromboembolic events; common side effects include conjunctival hemorrhage, eye pain, and cataract.