Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema

Summary

This is 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

Timeline

Start

2021-07-22

Primary completion

2022-10-14

Completion

2023-04-24

Outcome

Met primary endpoint

paper A 24-week phase 3 analysis previously demonstrated equivalent efficacy and comparable tolerability between candidate biosimilar CT-P42 and reference aflibercept PMID 40879891 ↗

release “was compared to Eylea® (aflibercept) in patients with diabetic macular edema (DME). Results of the study showed that Eydenzelt® met the predefined equivalence criteria” celltrion.com ↗

Publications

• Brown DM, Wolf S, Veselovsky M, Veith M, Papp A, Mange S, Mondal LK, Romanczak D, Janco L, Chauhan R, Romanowska-Dixon B, Eremina A, Dusova J, Sagong M, Kim S, Bae Y, Kim S, Bae Y, Son D, Kang H, Choi S, Stanga PE. Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. Ophthalmol Ther. 2025 Nov;14(11):2769-2783. doi: 10.1007/s40123-025-01197-w. Epub 2025 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	CT-P42	Unknown	2 mg	Intravitreal

Indications