Key Takeaways

  • Two peer-reviewed publications reported clinical data from the phase 3 INSIGHT program evaluating MYL-1701P in diabetic macular edema.
  • In a 20-week extension study, patients who continued MYL-1701P and those who switched from reference aflibercept had comparable safety, efficacy, and immunogenicity outcomes.
  • Exploratory subgroup analyses showed clinically comparable visual acuity and retinal thickness outcomes between MYL-1701P and reference aflibercept across most evaluated subgroups.

Biocon announced the publication of two peer-reviewed studies from the phase 3 INSIGHT program evaluating MYL-1701P, its aflibercept biosimilar approved by the FDA as Yesafili (aflibercept-jbvf), for the treatment of diabetic macular edema.1,2

The first study, published June 29, 2026, reported findings from a 20-week, multicenter, open-label extension study of participants with diabetic macular edema who completed the 52-week global phase 3 INSIGHT trial. The extension evaluated safety, efficacy, and immunogenicity in patients who either continued treatment with MYL-1701P or switched from reference aflibercept to MYL-1701P.1

According to Biocon, safety, efficacy, and immunogenicity profiles were comparable between the continuation and switch groups. Best corrected visual acuity, central subfield thickness, and ETDRS letter gains were maintained through the extension period in both treatment groups.

The second study, published May 18, 2026, presented exploratory subgroup analyses from the phase 3 INSIGHT randomized clinical trial. Subgroups were defined by baseline characteristics including visual acuity, central subfield thickness, age, gender, race, ethnicity, geographic region, glycated hemoglobin, antidrug antibody status, and prior anti-VEGF therapy in the fellow eye.2

The analyses showed clinically comparable changes in best corrected visual acuity and central subfield thickness between MYL-1701P and reference aflibercept across most subgroups at early and later timepoints, according to the company.

Yesafili is indicated for neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. The product was approved by the FDA in May 2024, and its vial format was granted interchangeable designation.

References

  1. Chauhan R, Gupta V, Natesh S, et al. Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial. BMJ Open Ophthalmol. 2026;11(2):e002637. 
  2. Bressler SB, Oleksy P, Alfaro DV, et al; on behalf of the INSIGHT Study Group. Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal phase 3 INSIGHT randomized clinical trial. Expert Opin Biol Ther. 2026;26(5):525-534.