Celltrion’s Eylea biosimilar shows efficacy in interim phase 3 results

Celltrion Inc. headquarters [Courtesy of Celltrion]

Celltrion Inc. said Monday that it has confirmed the efficacy and safety of its investigational ophthalmology biosimilar, CT-P42, based on interim results from a global Phase 3 clinical trial.

CT-P42 is a biosimilar to Regeneron’s eye drug, Eylea (aflibercept), which is used to treat conditions such as age-related macular degeneration and diabetic macular edema.

Celltrion is conducting a 52-week Phase 3 clinical trial on 348 patients with diabetic macular edema in 13 countries, including Germany and Spain. The interim results announced Monday cover the first 24 weeks of the trial.

In the trial, patients were randomized into two groups to receive either CT-P42 or Eylea. The best-corrected visual acuity, which refers to the best possible vision that an eye can achieve with the use of glasses or contact lenses, measured eight weeks after drug was administered compared with baseline was used to evaluate the efficacy of CT-P42.

As a result, CT-P42 met the equivalence criteria to the reference product. Celltrion also confirmed a similar trend in efficacy, safety, and immunogenicity compared to Eylea.

The company said it plans to complete its Phase 3 clinical trial and submit data for marketing approval of CT-P42 in major countries, including the U.S. and Europe, by the end of this year.