Biocon Limited announced the publication of pivotal clinical data supporting the effectiveness of Yesafili™ (aflibercept-jbvf), a biosimilar to Eylea® (aflibercept). The data, from the Phase III INSIGHT program evaluating MYL-1701P, were published in the British Journal of Ophthalmology on June 29, 2026, and Expert Opinion on Biological Therapy on May 18, 2026. The study in the British Journal of Ophthalmology demonstrated that patients continuing on MYL-1701P and those switching from reference aflibercept showed similar safety, efficacy, and immunogenicity outcomes through a 20-week extension, maintaining visual and anatomic results. The publication in Expert Opinion on Biological Therapy presented subgroup analyses showing MYL-1701P had comparable improvements in visual acuity and retinal thickness to reference aflibercept across diverse diabetic macular edema (DME) populations. Shreehas Tambe, CEO & Managing Director, Biocon, stated that these findings are an important milestone for their aflibercept biosimilar program as they prepare for launch in the United States, emphasizing the company's commitment to expanding access to biosimilars. Dr. Elena Wolff-Holz, Chief Medical Officer, Biocon, added that the data reinforce the clinical evidence and demonstrate consistency of outcomes and comparability across relevant patient subgroups, supporting MYL-1701P as a reliable treatment option for DME. Yesafili™ received approval and an interchangeable designation from the U.S. Food and Drug Administration in May 2024. It is indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
