Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

Summary

Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. The primary endpoint is mean change from baseline in Best Corrected Visual Acuity (BCVA) as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Pharmacokinetics (PK) and immunogenicity to be evaluated in the subjects participating in the study.

Timeline

Start

2018-08-23

Primary completion

2020-11-10

Completion

2021-09-10

Publications

• Chauhan R, Gupta V, Natesh S, Vohra R, Agarwal V, Ganapathi PC, Bose D, Loganathan S. Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial. BMJ Open Ophthalmol. 2026 Jun 29;11(2):e002637. doi: 10.1136/bmjophth-2025-002637.
• Bressler SB, Oleksy P, Alfaro DV, Apte RS, Barve A, Baumane K, Beckmann K, Degi R, Ernest J, Gupta V, Kamei M, Kishino G, Lorenz K, Marcus DM, Bose D, Ganapathi PC, Loganathan S. Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal Phase-III INSIGHT randomized clinical trial. Expert Opin Biol Ther. 2026 May;26(5):525-534. doi: 10.1080/14712598.2026.2672422. Epub 2026 May 18.
• Bressler SB, Barve A, Ganapathi PC, Beckmann K, Apte RS, Marcus DM, Baumane K, Agarwal S, Oleksy P, Reichstein DA, Patel SS, Ernest J, Degi R, Gupta V, Kishino G, Kamei M, Loganathan S; INSIGHT Study Group. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. JAMA Ophthalmol. 2024 Oct 1;142(10):952-960. doi: 10.1001/jamaophthalmol.2024.3458.

Drugs

Indications