Biocon Limited announced the publication of two pivotal clinical studies supporting the effectiveness of Yesafili™ (aflibercept-jbvf), its biosimilar to Eylea® (Aflibercept). The clinical data from the Phase III INSIGHT program was published in two peer-reviewed journals.

Key Publications and Findings

First Publication - British Journal of Ophthalmology (June 29, 2026):

  • Study Design: 20-week, multicenter, open-label extension study enrolling participants with Diabetic Macular Edema (DME) who completed the 52-week global Phase III INSIGHT trial
  • Key Findings: Participants 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
  • Safety assessed by incidence of ocular and non-ocular treatment-emergent adverse events
  • Efficacy outcomes included best corrected visual acuity, central subfield thickness, and participants who gained ETDRS (Early Treatment Diabetic Retinopathy Study) letters
  • Functional and anatomic outcomes were maintained through the extension period in both treatment groups

Second Publication - Expert Opinion on Biological Therapy (May 18, 2026):

  • Study Design: Exploratory subgroup analyses from the Phase III INSIGHT randomized clinical trial comparing MYL-1701P with reference aflibercept in participants with DME
  • Subgroups analyzed based on baseline characteristics including visual acuity, central subfield thickness, age, gender, race, ethnicity, geographic region, glycated hemoglobin, anti-drug antibody status, and prior anti-VEGF therapy
  • Key Findings: Clinically comparable changes in best corrected visual acuity and central subfield thickness between MYL-1701P and reference aflibercept across most subgroups at both early and later timepoints
  • Findings support clinical equivalence between the aflibercept biosimilar and reference product within evaluated subgroups

Regulatory Status and Product Information

Yesafili™ (aflibercept-jbvf) was approved and the vial format was granted interchangeable designation by the U.S. Food and Drug Administration in May 2024. The approval was based on a comprehensive package of analytical, nonclinical and clinical data confirming that YESAFILI is highly similar to Eylea®.

Indications and Usage:

YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for treatment of patients with:

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)

Warnings and Precautions:

  • Contraindicated in patients with ocular or periocular infection, active intraocular inflammation, and hypersensitivity to aflibercept
  • Potential risks include endophthalmitis, retinal detachments, retinal vasculitis with or without occlusion
  • Increases in intraocular pressure within 60 minutes of intravitreal injection
  • Potential risk of arterial thromboembolic events

Management Commentary

Shreehas Tambe, CEO & Managing Director, Biocon: "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."

Dr. Elena Wolff-Holz, Chief Medical Officer, Biocon: "The data from these publications reinforce the clinical evidence generated through the Phase III INSIGHT trial, demonstrating consistency of outcomes following a switch from reference aflibercept and comparability across clinically relevant patient subgroups. This adds to the growing body of evidence supporting MYL-1701P as a reliable treatment option for diabetic macular edema."

Epidemiology Context

The release provided epidemiological context noting:

  • 19.8 million Americans living with age-related macular degeneration (AMD)
  • AMD is a leading cause of irreversible vision loss in adults over 60
  • In 2019, estimated 12.6% of Americans age 40 and older had AMD, with 1.49 million (0.94%) living with vision-threatening AMD