Extension Study of MYL-1701P-3001 for Safety and Efficacy

Phase 3 Completed 52 enrolled Mylan Pharmaceuticals Inc Momenta Pharmaceuticals, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 study.

Timeline

Start: 2020-11-23
Primary completion: 2022-04-20
Completion: 2022-04-20

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MYL-1701P	Protein / enzyme biologic	2 mg	Intravitreal

Extension Study of MYL-1701P-3001 for Safety and Efficacy

Summary

Timeline

Publications

Drugs

Indications