Aflibercept 8 mg shows promise in treating diabetic macular edema: PHOTON Study

Aflibercept 8 mg for the treatment of diabetic macular edema (DMO) shows promising results in terms of efficacy and safety, according to results a Phase 2/3 clinical trial. Both dosing regimens of aflibercept 8 mg demonstrated non-inferior gains in visual acuity compared to the standard 2 mg dosage, while also showing similar rates of ocular adverse events.

The PHOTON study was conducted as a randomized, double-masked, non-inferiority, phase 2/3 trial across 138 hospitals and specialty retina clinics in seven countries. It aimed to compare the efficacy and safety of aflibercept 8 mg versus the standard 2 mg dosage in patients with DMO.

Over the course of the trial, 660 patients were enrolled and randomly assigned to receive either aflibercept 8 mg administered every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or the standard 2 mg dosage every 8 weeks (2q8). The primary endpoint of the study was the change from baseline in best-corrected visual acuity (BCVA) at week 48.

The findings revealed that both aflibercept 8 mg dosing regimens (8q12 and 8q16) demonstrated non-inferior BCVA gains compared to the standard 2 mg dosage (2q8). The mean change from baseline in BCVA was 8.8 letters for the 8q12 group, 7.9 letters for the 8q16 group, and 9.2 letters for the 2q8 group.

Reference
Brown DM, Boyer DS, Do DV, et al; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024 Mar 7:S0140-6736(23)02577-1. doi: 10.1016/S0140-6736(23)02577-1. Epub ahead of print. PMID: 38461843.