Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical...

Area of Science:

• Ophthalmology
• Endocrinology
• Pharmacology

Background:

• Diabetic macular edema (DME) is a leading cause of vision loss in diabetic patients.
• Biosimilars offer potential cost savings and expanded access to biologic treatments.
• Aflibercept is a standard treatment for DME, but biosimilar options have not been extensively studied in this indication.

Purpose of the Study:

• To evaluate the efficacy and safety of MYL-1701P, an aflibercept biosimilar, compared to reference aflibercept in patients with DME.
• To determine if MYL-1701P meets predefined equivalence margins for visual acuity and anatomical changes.

Main Methods:

• A double-masked, randomized clinical trial involving 355 participants across 77 centers globally.
• Participants received either MYL-1701P or reference aflibercept via intravitreal injections for 52 weeks.
• Primary outcome was the change in best-corrected visual acuity (BCVA) at week 8; secondary outcomes included central subfield thickness (CST), safety, and immunogenicity.

Main Results:

• MYL-1701P showed a mean change in BCVA of 6.60 letters versus 6.56 letters for aflibercept at week 8, meeting the primary efficacy endpoint (adjusted difference 0.04 letters).
• Both treatments resulted in comparable reductions in CST and similar incidences of ocular and nonocular adverse events.
• Immunogenicity, assessed by antidrug antibodies (ADAs), was also comparable between the two groups.

Conclusions:

• MYL-1701P is clinically equivalent to reference aflibercept in terms of efficacy for treating DME.
• The safety and immunogenicity profiles of MYL-1701P are comparable to reference aflibercept.
• These findings support the use of MYL-1701P as a cost-effective alternative for DME management.