Celltrion, Inc. announced that Health Canada has approved Eydenzelt, a biosimilar referencing Eylea (aflibercept 2mg), in both vial and pre-filled syringe format, for treatment of all indications approved for Eylea. The Health Canada approval is based on totality of evidence including analytical, nonclinical, and clinical data. A global, randomized, double-masked, parallel-group, multicenter Phase III study evaluated the efficacy, safety, and immunogenicity of Eydenzelt compared to Eylea in patients with approved indications.
The 52-week trial included 348 patients with diabetic macular edema (DME). The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing Eydenzelt and Eylea. Results of the study showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogeneicity also showed trends similar to Eylea.
Eydenzelt is Celltrion's first Health Canada-approved biologic product in ophthalmology. Eydenzelt was also approved by the European Commission (EC) and the U.S. Food and Drug Administration (FDA) in February and October 2025, respectively.
