Aflibercept 8 mg demonstrates greater therapeutic benefit versus aflibercept 2 mg in DME

The new data presented at ARVO 2023, demonstrated non-inferiority in BCVA with aflibercept 8 mg versus aflibercept 2 mg through 48 weeks in patients with diabetic macular edema (DME).

In the ongoing double-masked, non-inferiority study lasting 96 weeks, patients were randomized to receive aflibercept every 12 or 16 weeks after three monthly doses (8q12 or 8q16) or every 8 weeks after five monthly doses (2q8). Patients in the 8q12 or 8q16 arms received shorter intervals of aflibercept if they met specific disease activity criteria between Weeks 16-48. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) from baseline at Week 48, with a non-inferiority margin of 4 letters. The key secondary endpoint was the proportion of patients with at least a two-step improvement in the diabetic retinopathy severity score (DRSS) at Week 48, with a non-inferiority margin of 15%. An exploratory endpoint evaluated the mean change from baseline in total fluorescein leakage area at Week 48 per reading center.

 The study compared the efficacy and safety of different dosing regimens of aflibercept for diabetic macular edema (DME) treatment over 48 weeks. The mean BCVA change from baseline was higher in the 2q8 and 8q12 groups compared to the 8q16 group. The 8q12 group was non-inferior to the 2q8 group for the proportion of patients with a two-step improvement from baseline in DRSS score. The safety outcomes were similar between the 8 mg and 2 mg doses. The majority of patients maintained their original dosing interval throughout the study.

Reference
Do DV, et al. Aflibercept 8 mg for Diabetic Macular Edema: 48-Week Results From the Phase 2/3 PHOTON Trial. Presented at: ARVO 2023.