Key findings published in the British Journal of Ophthalmology: Patients who continued on MYL‑1701P and those who switched from reference aflibercept to MYL‑1701P showed similar safety, efficacy, and immunogenicity outcomes through the 20‑week extension, with maintained visual and anatomic results.
Key findings published in Expert Opinion on Biological Therapy: Across clinically relevant patient subgroups, MYL‑1701P demonstrated comparable improvements in visual acuity and retinal thickness to reference aflibercept, supporting clinical equivalence across diverse DME populations.
BENGALURU, India & BRIDGEWATER, N.J., July 09, 2026--(BUSINESS WIRE)--Biocon Limited (BSE: 532523; NSE: BIOCON), an innovation‑led global biopharmaceutical company, today announced the publication of two important clinical studies supporting the effectiveness of Yesafili™ (aflibercept-jbvf). The clinical data from the Phase III INSIGHT program evaluating MYL‑1701P, its aflibercept biosimilar, was published in two peer-reviewed journals, contributing to the clinical evidence base supporting the development of aflibercept MYL‑1701P for the treatment of diabetic macular edema (DME). MYL-1701P was approved and the vial format was granted interchangeable designation under the name Yesafili™ by the U.S. Food and Drug Administration in May 2024.
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."
Safety and Efficacy of Biosimilar Aflibercept MYL‑1701P in Diabetic Macular Oedema: 20‑Week Extension Results Following the INSIGHT Pivotal Trial
The first manuscript, 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.
This publication reports results from a 20‑week, multicenter, open‑label extension study enrolling participants with Diabetic Macular Edema (DME) who completed the 52‑week global Phase III INSIGHT trial. The study evaluated the safety, efficacy and immunogenicity of MYL‑1701P in participants who either continued treatment with MYL‑1701P or switched from reference aflibercept to MYL‑1701P.
The results demonstrated comparable safety, efficacy, and immunogenicity profiles between participants who continued on MYL‑1701P and those who switched from reference aflibercept. Safety was assessed by the incidence of ocular and non-ocular treatment‑emergent adverse events, while efficacy outcomes included best corrected visual acuity, central subfield thickness and participants who gained ETDRS (Early Treatment Diabetic Retinopathy Study) letters. The findings demonstrate that functional and anatomic outcomes were maintained through the extension period in both treatment groups.