Nam Hyun-woo has worked as a staff writer at The Korea Times since 2013, mostly covering business and politics. He currently belongs to the Business Desk where he covers topics such as emerging tech, AI, ICT and Korea's chaebol community. Prior to joining the team, he was the paper's correspondent for the presidential office of Korea during the Yoon Suk Yeol and Moon Jae-in administrations.
Celltrion’s eye disease treatment wins FDA approval
Celltrion's Eydenzelt / Courtesy of Celltrion
By Nam Hyun-woo
Celltrion said Friday that its eye disease treatment Eydenzelt won approval from the U.S. Food and Drug Administration (FDA), opening access to a $6 billion market.
According to the biotech firm, the FDA approved two formulations of Eydenzelt: a vial and a prefilled syringe.
Eydenzelt is a biosimilar referencing Eylea, which is developed by Regeneron Pharmaceuticals. Eylea is a blockbuster treatment for common causes of blindness in the elderly that posted global sales of $9.52 billion last year. In the U.S., the world’s largest pharmaceutical market, the drug generated $5.97 billion in sales.
In its phase 3 clinical trial involving 348 patients, Celltrion confirmed the equivalence of Eydenzelt to the original drug. Based on the results, the company obtained U.S. approval for all adult indications held by the reference drug, including neovascular age-related macular degeneration and macular edema following retinal vein occlusion.
Celltrion has won regulatory approvals for Eydenzelt in major markets, including Korea, Europe, Australia and the U.S. The company recently published the 52-week results of its global Phase 3 clinical trial in leading international ophthalmology journals, sharing long-term data that demonstrates the drug’s efficacy and safety and enhances physicians’ confidence in prescribing it.
Eydenzelt is Celltrion’s fifth biologic to obtain U.S. approval this year, following its autoimmune disease treatment Aptozma, bone disorder drugs Stoboclo and Osenvelt, and allergy treatment Omlyclo. With the addition of these five products, the company has significantly strengthened its presence in the global market.
“With the approval of Eydenzelt, Celltrion will be able to expand its portfolio and market presence in the world’s largest pharmaceutical market,” a Celltrion official said. “We will swiftly complete the remaining commercialization process in the U.S. and make every effort to ensure that high-quality biologics are supplied to more patients as soon as possible.”