One-year data from the INSIGHT study, published this month in JAMA Ophthalmology, indicates that MYL-1701P (Momenta Pharma/Viatris), an aflibercept biosimilar, is as effective as the original drug (Eylea; Regeneron) in treating diabetic macular edema (DME).

The randomized, double-masked INSIGHT trial, which involved 355 participants worldwide, showed that MYL-1701P matched the efficacy of the reference aflibercept 2 mg in improving BCVA over 52 weeks. At week 8, mean change in BCVA, measured by EDTRS letters, was a gain of 6.60±0.55 letters in the MYL-1701P group (n=179) vs 6.56±0.55 letters in the aflibercept group (n=176); this met the study’s primary endpoint. Mean change in central subfield thickness (CST) was −112±7 μm in the MYL-1701P group vs −124±7 μm in the aflibercept group at week 8, a key secondary outcome. 

“MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept,” the researchers concluded.