Proposed Aflibercept Biosimilar Provides Comparable Efficacy, Safety for DME

Aflibercept (Eylea) biosimilar MYL-1701P showed therapeutic equivalence to the marketed anti-VEGF therapy among patients with diabetic macular edema (DME), according to new data from the INSIGHT Study.

In new findings presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting in Chicago this week, the Viatris and Momenta Pharmaceuticals biosimilar MYL-1701P was associated with similar rates of meaningful visual acuity (VA) change among patients with DME as those who were treated with aflibercept.

Similarly reporting good safety and tolerability, the proposed biosimilar may become a more accessible anti-VEGF option for patients with the common form of vision loss.

Led by Susan B. Bressler, MD, of the Wilmer Institute at Johns Hopkins University School of Medicine, a team of sponsored investigators conducted the INSIGHT trial to interpret the clinical equivalence of MYL-1701P to aflibercept. They sought a primary endpoint of time to best-corrected VA (BCVA) at week 8, as well as a secondary analysis of proportion of patients who gained ≥15 ETDRS letters from baseline and safety outcomes.
The intravitreal injection aflibercept biosimilar was developed by Viatris under the regulatory pathways of both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Bressler and colleagues used a trial population of 355 patients from 9 countries with central DME and baseline ETDRS letter scores of 38 - 73.

Patients were randomized 1:1 to either aflibercept (n = 176) or MYL-1701P (n = 179), with doses and regimens set to those on the aflibercept label. Treatment for the trial continued through week 48, with follow-up to week 52.

Investigators observed an adjusted mean change of 6.60 ETDRS letters from baseline in patients treated with MYL-1701P at week 8. Among patients, the difference from baseline was 6.56, indicating a BCVA improvement difference of 0.04 letters (95% CI, -1.40 to 1.47).

In the secondary analysis, 61.4% of patients achieved a BCVA improvement of ≥5 letters through 8 weeks when treated with the biosimilar versus 62.8% of patients treated with aflibercept. Rates of improvement were similar for both ≥10 and ≥15 letters, indicating therapeutic equivalence.

Approximately three-fourths of patients in the MYL-1701P and aflibercept treatment arms each reported treatment-emergent adverse events; treatment was discontinued due to the adverse events in 3 patients from each arm.

Bressler and colleagues additionally observed comparable immunogenicity between the 2 agents through 52 weeks. The team concluded that MYL-1701P provided similar efficacy per BCVA change at 8 weeks as aflibercept, as well as comparable safety outcomes and long-term immunogenicity.

“Following regulatory approval, MYL-1701P is expected to be a new treatment option for patients with DME,” they wrote.

The study, “MYL-1701P (Proposed Biosimilar Aflibercept) Compared to Eylea in DME: Outcomes From the Phase 3 INSIGHT Study,” was presented at AAO 2022.