Biocon publishes peer‑reviewed Phase III INSIGHT data in British Journal of Ophthalmology and Expert Opinion on Biological Therapy, confirming Yesafili (aflibercept‑jbvf) delivers long‑term safety, efficacy, and interchangeability with Eylea in diabetic macular edema.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
Biocon has published two peer-reviewed clinical studies from its Phase III INSIGHT program that further strengthen the evidence supporting Yesafili (aflibercept-jbvf; MYL-1701P), its interchangeable aflibercept biosimilar for diabetic macular edema (DME). The publications, appearing in the British Journal of Ophthalmology and Expert Opinion on Biological Therapy, demonstrate sustained efficacy, comparable safety, and low immunogenicity after switching from reference aflibercept, while confirming consistent clinical performance across multiple patient subgroups.
The new publications add to the clinical evidence supporting Yesafili, which received U.S. Food and Drug Administration approval with interchangeable designation for its vial presentation in May 2024. The approval was based on a comprehensive analytical, nonclinical, and clinical comparability package demonstrating high similarity to the reference product, Eylea.
Peer-Reviewed Evidence Supports Long-Term Comparability
The first study, The 20-week extension study (ClinicalTrials.gov: NCT04674800) enrolled participants who completed the parent Phase III INSIGHT trial (NCT03610646), which was previously published in JAMA Ophthalmology. The extension enrolled participants with DME who had completed the original 52-week study and evaluated outcomes in patients who either continued MYL-1701P or switched from reference aflibercept.
Investigators observed comparable safety, efficacy, and immunogenicity between both treatment groups throughout the extension period. Functional outcomes, including best-corrected visual acuity (BCVA), remained stable, while anatomical improvements measured by central subfield thickness were maintained. The incidence of ocular and non-ocular treatment-emergent adverse events also remained similar after the switch, supporting the biosimilar’s long-term clinical consistency.
Subgroup Analysis Reinforces Clinical Equivalence
The second publication, released in Expert Opinion on Biological Therapy on May 18, 2026, presented exploratory subgroup analyses from the randomized Phase III INSIGHT trial. Researchers evaluated treatment outcomes across clinically relevant baseline characteristics, including age, sex, race, ethnicity, geographic region, glycated hemoglobin levels, baseline visual acuity, retinal thickness, anti-drug antibody status, and previous anti-VEGF therapy in the fellow eye.
Across most evaluated subgroups, MYL-1701P produced clinically comparable improvements in BCVA and central subfield thickness relative to reference aflibercept at both early and later assessment timepoints. These findings support consistent therapeutic performance across a broad DME population.
Clinical Significance
Aflibercept is an anti-vascular endothelial growth factor (anti-VEGF) therapy that inhibits abnormal retinal blood vessel leakage and neovascularization, key drivers of vision loss in diabetic macular edema. Biosimilars with demonstrated clinical equivalence and interchangeability can improve treatment access while reducing healthcare costs without compromising efficacy or safety.
Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon, said the peer-reviewed publications represent an important milestone for the company’s aflibercept biosimilar program as it prepares for commercial launch in the United States.
Chief Medical Officer Dr. Elena Wolff-Holz added that the studies reinforce evidence supporting treatment continuity following a switch from reference aflibercept and demonstrate consistent outcomes across clinically relevant patient populations.
Path Forward
Together, the two publications expand the scientific evidence supporting Yesafili’s clinical comparability with reference aflibercept. The additional long-term and subgroup data are expected to strengthen physician confidence in switching strategies and support broader adoption of the interchangeable biosimilar as Biocon advances its U.S. commercialization plans.
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About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.