Biocon Limited (BSE: 532523 | NSE: BIOCON), a global biopharmaceutical company, has announced the publication of two peer-reviewed clinical studies supporting the safety and efficacy of Yesafili™ (aflibercept-jbvf), its biosimilar to Eylea® (aflibercept), for the treatment of diabetic macular edema (DME). The publications strengthen the clinical evidence supporting the company’s aflibercept biosimilar programme ahead of its planned commercial expansion in the United States.
The studies are based on data generated through the Phase III INSIGHT clinical programme evaluating MYL-1701P, Biocon’s aflibercept biosimilar. Yesafili received approval from the U.S. Food and Drug Administration in May 2024, with the vial presentation also designated as interchangeable, enabling greater flexibility for healthcare providers and patients.
The first study, titled Safety and Efficacy of Biosimilar Aflibercept MYL-1701P in Diabetic Macular Oedema: 20-Week Extension Results Following the INSIGHT Pivotal Trial, was published in the British Journal of Ophthalmology on June 29, 2026. The multicentre, open-label extension study followed participants who had completed the 52-week global Phase III INSIGHT trial.
The findings demonstrated that patients who continued treatment with MYL-1701P and those who transitioned from the reference aflibercept therapy achieved comparable safety, efficacy and immunogenicity outcomes. Clinical assessments included best corrected visual acuity, central retinal thickness and improvements in Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores, alongside monitoring of ocular and systemic adverse events.
Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon Limited, said, “The publication of these peer-reviewed studies represents an important milestone for our aflibercept biosimilar programme. The findings reinforce the strength of our scientific and clinical development capabilities while supporting our objective of expanding access to high-quality biosimilars for patients requiring retinal disease treatment.”
Dr Elena Wolff-Holz, Chief Medical Officer, Biocon, added, “The data further validate the consistency of clinical outcomes observed in the Phase III INSIGHT programme, including patients who switched from the reference product. These findings contribute to the growing body of evidence supporting MYL-1701P as an effective and reliable treatment option for diabetic macular edema.”
Diabetic macular edema and age-related macular degeneration remain among the leading causes of vision impairment globally, highlighting the need for broader access to effective biological therapies. Through its expanding biosimilars portfolio, Biocon continues to focus on improving treatment accessibility across ophthalmology and other chronic disease segments.
Headquartered in Bengaluru, Biocon operates in more than 120 countries with a portfolio spanning biosimilars, generic formulations and complex biologics. The company has commercialised 12 biosimilars and over 30 generic products globally and continues to advance a robust research pipeline across multiple therapeutic areas while expanding access to affordable medicines worldwide.
