Biocon has announced the publication of new clinical data reinforcing the effectiveness and safety profile of Yesafili (aflibercept-jbvf), its biosimilar to Eylea (aflibercept), with two peer-reviewed studies showing comparable outcomes across diabetic macular edema (DME) patient groups.
The findings, drawn from the Phase III INSIGHT clinical program evaluating MYL-1701P, revealed that patients who continued treatment with MYL-1701P and those who switched from reference aflibercept achieved similar safety, efficacy, and immunogenicity outcomes, with sustained visual and anatomical improvements.
MYL-1701P was approved by the U.S. Food and Drug Administration in May 2024, with the vial presentation receiving interchangeable designation under the name Yesafili™.
Shreehas Tambe, CEO & Managing Director, Biocon, said, “Findings from these peer-reviewed publications represent an important milestone for our aflibercept biosimilar program as we prepare for our upcoming launch in the United States. Together, these studies demonstrate how our science-led approach continues to expand access to biosimilars for patients.”
The first studyn8s titled “Safety and Efficacy of Biosimilar Aflibercept MYL-1701P in Diabetic Macular Oedema: 20-Week Extension Results Following the INSIGHT Pivotal Trial."
The 20-week multicenter extension study evaluated participants with diabetic macular edema who had completed the 52-week global Phase III INSIGHT trial. Researchers assessed patients who either continued receiving MYL-1701P or switched from reference aflibercept.
Results showed comparable safety, efficacy, and immunogenicity profiles between both groups. Measures including best corrected visual acuity, central subfield thickness, and ETDRS letter gains remained consistent, indicating that functional and anatomical improvements were maintained after treatment continuation or switching.
The second, “Comparability of Aflibercept Biosimilar with Reference Aflibercept in Diabetic Macular Edema: Subgroup Analysis of the Pivotal Phase-III INSIGHT Randomized Clinical Trial,” examined outcomes across clinically relevant subgroups, including differences in baseline visual acuity, retinal thickness, age, gender, race, ethnicity.
Across most evaluated subgroups, MYL-1701P demonstrated comparable improvements in best corrected visual acuity and central subfield thickness compared with reference aflibercept, supporting clinical equivalence between the biosimilar and the reference product.
Elena Wolff-Holz, Chief Medical Officer, Biocon, said, “The data from these publications reinforce the clinical evidence generated through the Phase III INSIGHT trial, demonstrating consistency of outcomes following a switch from reference aflibercept and comparability across clinically relevant patient subgroups. This adds to the growing body of evidence supporting MYL-1701P as a reliable treatment option for diabetic macular edema."