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Celltrion Secures FDA Approval for EYDENZELT®: Expanding U.S. Ophthalmology Options

11 Oct 2025
Admin
News Article

Celltrion Secures FDA Approval for EYDENZELT®: Expanding U.S. Ophthalmology Options

Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar to EYLEA® (aflibercept), for the treatment of:

Neovascular (wet) age-related macular degeneration (wAMD)
Macular edema following retinal vein occlusion (RVO)
Diabetic macular edema (DME)
Diabetic retinopathy (DR)

EYDENZELT works by blocking VEGF-A and placental growth factor (PlGF), inhibiting abnormal blood vessel growth and reducing fluid leakage in the eye.

“Timely access to effective therapies is essential for individuals affected by retinal diseases. EYDENZELT’s approval will broaden options and improve patient outcomes.”

Dr. Juby Jacob-Nara, SVP & CMO, Celltrion USA.

Key Evidence Behind FDA Approval

Phase III trial: 348 patients with DME over 52 weeks.
Endpoints met: Best corrected visual acuity at week 8 showed therapeutic equivalence to EYLEA®.
Safety profile: Comparable to EYLEA®, with no new safety signals.

“EYDENZELT will be an important addition to our retinal disease treatment options.”

Dr. David M. Brown, Director, Retina Consultants of Texas Research Centers.

What This Means for Patients

First FDA-approved ophthalmology biologic from Celltrion.
Expanded access to high-quality, cost-effective biosimilar therapy.
Provides physicians with more flexibility in managing serious retinal conditions.

About EYDENZELT®

Mechanism: VEGF inhibitor blocking abnormal ocular angiogenesis.
Indications: wAMD, RVO-related macular edema, DME, DR.
Safety considerations: Monitor for intraocular pressure spikes, thromboembolic events, ocular infections, and hypersensitivity reactions. Common adverse events include eye pain, cataract, vitreous detachment, floaters, and conjunctival hemorrhage.

About Celltrion, Inc.

Celltrion is a leading biopharma company pioneering biosimilars and novel biologics. Their U.S. subsidiary, Celltrion USA, focuses on improving access to innovative treatments and currently markets ten FDA-approved biosimilars along with novel therapies.

EYDENZELT also received European Commission approval in February 2025, marking another milestone for Celltrion in ophthalmology.