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Celltrion Secures FDA Approval for EYDENZELT®

Celltrion, Inc., a South Korean biopharmaceutical leader, has recently achieved a significant milestone by obtaining approval from the U.S. Food and Drug Administration (FDA) for its new product, EYDENZELT® (aflibercept-boav). This biosimilar is designed to reference the well-known EYLEA® (aflibercept) and is aimed at treating several serious ocular conditions, including neovascular (wet) age-related macular degeneration (wAMD), macular edema post-retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

The approval marks a pivotal step for Celltrion as it expands its presence in the U.S. ophthalmology market, catering to a wide array of patients faced with different eye health challenges. “Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have EYDENZELT approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the U.S.,” stated Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA.

The Science Behind EYDENZELT®

EYDENZELT® functions as a vascular endothelial growth factor (VEGF) inhibitor, which is pivotal in mitigating the growth of new blood vessels and reducing fluid leakage through blood vessels in the eye, a process that underlies many retinal diseases. This therapy works by blocking key growth factors, specifically VEGF-A and placental growth factor (PlGF), which are crucial in the development of ocular angiogenesis.

A comprehensive FDA review included a robust totality of evidence incorporating analytical, nonclinical, and clinical data. This culminated in a multicenter randomized phase III clinical trial that assessed EYDENZELT® against EYLEA® in patients suffering from DME. The trial involved 348 participants and successfully met primary efficacy endpoints, showcasing that EYDENZELT® is clinically comparable to its reference product.

Dr. David M. Brown of the Retina Consultants of Texas Research Centers emphasized the significance of EYDENZELT®: “Advanced age-related macular degeneration (AMD) is a leading cause of irreversible blindness and visual impairment in the world, with nearly 20 million people in the U.S. living with some form of AMD. EYDENZELT will be an important new addition to our treatment options for patients with serious retinal diseases.”

Implications for Patients and Healthcare Providers

The approval of EYDENZELT® is not just a win for Celltrion but also a promise of enhanced treatment options for patients battling severe ocular diseases. Given the extensive prevalence of conditions like AMD and diabetic retinopathy, products like EYDENZELT® are essential in providing physicians with diverse therapeutic alternatives, ultimately aiming for improved patient outcomes.

As Celltrion continues to advance its portfolio, EYDENZELT® stands out as its first FDA-approved biologic product in the field of ophthalmology. This accomplishment builds on Celltrion’s legacy as an innovator in the biosimilar landscape, having pioneered the development of the world’s first monoclonal antibody biosimilar.

Conclusion

With international approval already granted by the European Commission earlier this year, Celltrion is setting a transformative path in the biotechnology space, providing high-quality biopharmaceuticals globally. For more information on Celltrion and its innovations in biotechnology, visit Celltrion's official website and keep abreast of their latest updates on various social media platforms.

About Celltrion, Inc.
Celltrion, Inc. specializes in research, development, manufacturing, and sales of innovative therapeutics aimed at improving global healthcare. With a commitment to pioneering biosimilars and advancing clinical science, Celltrion continues to enhance treatment approaches across multiple therapeutic areas.

For further inquiries, contact Katie Gallagher at [email protected].