Celltrion has received approval from the U.S. Food and Drug Administration (FDA) for EYDENZELT® (aflibercept-boav), a biosimilar referencing EYLEA® (aflibercept). 

Age-related macular degeneration (AMD) remains one of the leading causes of irreversible blindness and visual impairment worldwide, affecting nearly 20 million people in the United States. The approval of EYDENZELT offers an additional treatment option for individuals living with retinal diseases and supports broader access to biological therapies across the country.

Aflibercept, a vascular endothelial growth factor (VEGF) inhibitor administered by injection into the eye, helps prevent the formation of abnormal blood vessels and reduces fluid leakage by blocking VEGF-A and placental growth factor (PlGF), both of which play a role in ocular angiogenesis.

EYDENZELT® (aflibercept-boav) is a VEGF inhibitor referencing EYLEA® (aflibercept). It is approved in the United States for the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, and diabetic retinopathy. The approval was based on comprehensive data confirming its therapeutic equivalence to EYLEA®.

The therapy is indicated for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME), and diabetic retinopathy (DR).

The FDA approval was supported by comprehensive evidence, including analytical, non-clinical, and clinical data. A phase III, randomised, double-masked, multicentre study compared the efficacy, safety, pharmacokinetics, and immunogenicity of EYDENZELT with EYLEA in 348 patients diagnosed with diabetic macular oedema. The 52-week study demonstrated equivalent outcomes between both treatments in terms of visual improvement, safety profile, and immune response.

EYDENZELT marks Celltrion’s first FDA-approved biologic product in ophthalmology. The therapy also received approval from the European Commission (EC) in February 2025.

Source: prnewswire.com