Celltrion announced global Phase 3 results for CT-P42, a biosimilar to EYLEA for the treatment of ocular diseases, at the American Society of Retina Specialists (ASRS) meeting on July 30.
The ASRS, now in its 41st year, is the world's preeminent international meeting on ophthalmic diseases and is being held in Seattle, USA, from July 28 to August 1.
In an oral presentation during the "Late-breaking Abstracts" session on the third day of the meeting, Celltrion presented detailed data from the global Phase 3 study, which enrolled 348 patients with diabetic macular edema (DME) in 13 countries, including Spain, Hungary and the Czech Republic.
Celltrion randomized patients into two groups, CT-P42 and original drug, with the primary endpoint of change in best corrected visual acuity (BCVA) measured at week 8 from baseline.
The results showed that CT-P42 met the predefined equivalence criterion of ±3 letters, and the secondary endpoints of efficacy, safety, and immunogenicity showed similar trends to the original drug.
Based on these clinical results, Celltrion recently completed the application for marketing authorization of CT-P42 with the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety. In the future, the company plans to apply for licenses in other major global countries such as Europe.
Meanwhile, EYLEA is a blockbuster product developed by Regeneron, a U.S. company, for the treatment of eye diseases, with global sales of $9.659 billion last year. EYLEA is used to treat Wet Age-Related Macular Degeneration (wAMD) and diabetic macular edema.
