Biocon Ltd. announced the publication of two peer-reviewed clinical studies validating the safety and efficacy of Yesafili™ (aflibercept-jbvf), its biosimilar to Eylea®, reinforcing the clinical evidence ahead of its planned launch in the US market.

The studies, based on the Phase III INSIGHT clinical program, demonstrated that Yesafili delivered safety, efficacy, and immunogenicity outcomes comparable to the reference aflibercept in the treatment of diabetic macular edema (DME). The findings also showed that patients switching from the reference drug to Yesafili maintained similar clinical outcomes.

The first study, published in the British Journal of Ophthalmology, reported positive results from a 20-week extension of the Phase III INSIGHT trial, confirming sustained visual and anatomical improvements in patients who either continued on Yesafili or transitioned from the reference product.

The second study, published in Expert Opinion on Biological Therapy, analyzed multiple patient subgroups and found consistent improvements in visual acuity and retinal thickness, further supporting the biosimilar's clinical equivalence across diverse patient populations.

Biocon noted that the publications add to the growing body of evidence supporting Yesafili as a reliable treatment option for DME. The biosimilar received approval from the US FDA, along with an interchangeable designation for its vial formulation, in May 2024.