Biocon Limited today announced the publication of pivotal clinical data supporting Yesafili, its biosimilar to Eylea® (aflibercept), in two peer-reviewed journals. The clinical evidence expands the data supporting development of aflibercept MYL-1701P for diabetic macular edema treatment.
The study published in British Journal of Ophthalmology on June 29, 2026, reports 20-week extension results from the Phase III INSIGHT pivotal trial. Patients who continued on MYL-1701P and those who switched from reference aflibercept showed similar safety, efficacy, and immunogenicity outcomes with maintained visual and anatomic results.
Results published in Expert Opinion on Biological Therapy on May 18, 2026, present subgroup analyses from the Phase III INSIGHT trial. Across clinically relevant patient subgroups defined by visual acuity, age, gender, race, prior anti-VEGF therapy, and other factors, MYL-1701P demonstrated comparable improvements in visual acuity and retinal thickness to reference aflibercept.
Yesafili (aflibercept-jbvf) received FDA approval with interchangeable designation in May 2024 based on analytical, nonclinical, and clinical data. The Phase III INSIGHT Study demonstrated no clinically meaningful differences between Yesafili and Eylea in pharmacokinetics, safety, efficacy, and immunogenicity.
Biocon Limited (BSE: 532523, NSE: BIOCON) is a global biopharmaceutical company headquartered in Bengaluru, India, with operations in more than 120 countries and 9,500 employees. The company has commercialized 12 biosimilar products and 30+ generic formulations globally, supported by 20+ biosimilar assets in its R&D pipeline.
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