Celltrion said it presented the 24-week results from its global phase 3 clinical trial of CT-P42, a biosimilar referencing Eylea (ingredient: aflibercept).

Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Eylea is expected to reach substance patent expiration in the U.S. in June 2023 and in Europe in May 2025.

Celltrion has been conducting a 52-week trial in 348 patients with diabetic macular edema (DME) in 13 countries, including Germany and Spain.

The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, with one group receiving CT-P42 and the other receiving Eyela.

The results showed that CT-P42 met the predefined equivalence criteria of ±3 letters, and secondary endpoints of efficacy, safety, and immunogenicity also showed similar trends to Eyela.

Celltrion plans to finish conducting the remaining phase 3 study and file for licensure of CT-P42 in the U.S. and Europe later this year.

“CT-P42 confirmed equivalence and similarity compared to Eylea in the 24-week global phase 3 clinical trial results,” a Celltrion official said. “We look forward to completing the remainder of the clinical program and accelerating the filing of a global license application later this year.”