INCHEON, South Korea, Oct. 9, 2025 — Celltrion, Inc., a global biopharmaceutical innovator, announced that the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar referencing EYLEA®, 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). This milestone marks Celltrion’s first FDA-approved biologic in ophthalmology, strengthening its presence in the U.S. eye care market.
Science Significance
EYDENZELT® is a vascular endothelial growth factor (VEGF) inhibitor designed to block ocular angiogenesis by targeting VEGF-A and placental growth factor (PlGF). These growth factors are critical drivers of abnormal blood vessel formation and vascular leakage in retinal diseases. By inhibiting these pathways, EYDENZELT reduces fluid accumulation in the retina and slows disease progression. Clinical validation was achieved through a rigorous phase III study comparing EYDENZELT with its reference product EYLEA in 348 patients with diabetic macular edema. The randomized, double-masked, multicenter trial demonstrated equivalent efficacy, safety, pharmacokinetics, and immunogenicity, confirming therapeutic comparability. Patients experienced improvements in best-corrected visual acuity at week 8, and secondary endpoints mirrored those of EYLEA. Dr. David M. Brown, Director at Retina Consultants of Texas Research Centers, emphasized the medical significance: “EYDENZELT will be an important new addition to our treatment options for patients with serious retinal diseases.” Given that nearly 20 million Americans live with some form of age-related macular degeneration, the approval represents a meaningful advance in vision care.
Regulatory Significance
EYDENZELT’s FDA approval reflects a totality of evidence encompassing analytical, nonclinical, and clinical data. The decision underscores the FDA’s commitment to facilitating access to safe and effective biosimilars while maintaining high standards for equivalence and patient safety. Approval in the U.S. follows earlier European Commission authorization in February 2025, demonstrating international regulatory alignment for biosimilars and reinforcing EYDENZELT’s global credibility. According to Dr. Juby Jacob-Nara, Senior VP and Chief Medical Officer at Celltrion USA, “Timely access to effective therapies is essential for individuals affected by retinal diseases, and FDA approval will help broaden physicians’ treatment options.”
Business Significance
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Celltrion plans to leverage EYDENZELT to enter the U.S. ophthalmology market, targeting diverse patient populations across multiple retinal conditions. This move represents a strategic expansion of Celltrion’s biologics portfolio, which already includes ten FDA-approved biosimilars and one novel biologic, ZYMFENTRA®. The U.S. ophthalmology market is valued at billions annually, driven by increasing prevalence of age-related eye diseases and diabetic complications. EYDENZELT’s introduction provides physicians and healthcare providers with a cost-effective alternative to EYLEA, potentially enhancing treatment accessibility and adoption.
Patients’ Significance
For patients, EYDENZELT offers a clinically equivalent option to an established VEGF inhibitor, potentially reducing financial burden and increasing treatment availability. Its approval supports personalized care strategies for wAMD, RVO, DME, and DR, diseases that, if untreated, can lead to irreversible vision loss. Patients are advised to monitor for adverse effects, including ocular infection, intraocular inflammation, increased intraocular pressure, and rare arterial thromboembolic events. Eye care professionals should follow established guidelines to manage potential complications promptly.
Policy Significance
EYDENZELT’s approval highlights the role of biosimilars in enhancing healthcare sustainability. By providing clinically comparable, cost-effective alternatives to branded biologics, biosimilars support healthcare affordability and broader patient access. Policymakers are increasingly encouraging biosimilar adoption to reduce treatment costs and optimize resource allocation in ophthalmology and other therapeutic areas.
Transaction Highlights
Celltrion’s FDA approval of EYDENZELT® represents a significant milestone as the company’s first ophthalmology biologic authorized in the U.S. The approval positions EYDENZELT as a biosimilar referencing EYLEA®, one of the leading VEGF inhibitors worldwide, offering clinicians and patients a clinically equivalent treatment alternative. This achievement is backed by robust Phase III data from 348 patients demonstrating equivalence in efficacy, safety, and immunogenicity compared to the reference product. Following the European Commission’s approval in February 2025, this U.S. authorization reflects global regulatory validation and strengthens Celltrion’s biosimilar portfolio. The anticipated U.S. launch will enhance the company’s market penetration and presence in ophthalmology, reinforcing its reputation as a pioneer in biosimilars while providing broader access to innovative therapies for patients with serious retinal diseases.
Source: Celltrion Press Release
