Trial Profile

A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 23 Apr 2025

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At a glance

15 Apr 2025 According to he U.S. Food and Drug Administration (U.S. FDA) approved Yesafili, an interchangeable biosimilar aflibercept in May 2024. The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea in patients with Diabetic Macular Edema.
01 Oct 2024 Results comparing the efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME, presented in the JAMA Ophthalmology
11 Oct 2021 Status changed from active, no longer recruiting to completed.

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