Trial Profile

A Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 12 Dec 2025

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At a glance

27 Nov 2025 According to cellrion media release, company 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.
09 Oct 2025 According to cellrion media release, the U.S. FDA has approved EYDENZELT (aflibercept-boav), biosimilar for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) based on the data from the trial.
07 Jul 2023 This trial has been completed in Poland, according to European Clinical Trials Database record.

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