Aflibercept 8 Mg in DME: 96-Week PHOTON Results

Key Takeaways

• At week 96, best-corrected visual acuity gains and central retinal thickness reductions were comparable across the aflibercept 8 mg extended-interval groups and the aflibercept 2 mg every-8-week group.
• Fewer active injections were observed with aflibercept 8 mg, and most patients who completed week 96 maintained at least their assigned 12- or 16-week interval, with substantial proportions qualifying for 20- and 24-week intervals.
• Ocular treatment-emergent adverse events in the study eye were similar across treatment groups.

Mean active injections through week 96 were 9.5 with every-12-week dosing and 7.8 with every-16-week dosing, compared with 13.8 for aflibercept 2 mg every 8 weeks. The 96-week results extend the durability findings from this randomized comparison.

The randomized phase 2/3 PHOTON study was a double-masked, 96-week, noninferiority trial in adults aged 18 years or older. Eligible participants had center-involved diabetic macular edema and baseline best-corrected visual acuity of 78 to 24 letters. Randomization was 1:2:1 to aflibercept 2 mg every 8 weeks, aflibercept 8 mg every 12 weeks, or aflibercept 8 mg every 16 weeks after initial monthly dosing. Overall, 658 patients received treatment, including 328 in the 8q12 arm, 163 in the 8q16 arm, and 167 in the 2q8 arm, and 534 completed week 96.

At week 96, mean best-corrected visual acuity change from baseline was +8.8 letters with 8q12, +7.5 letters with 8q16, and +8.4 letters with 2q8. Mean central retinal thickness change from baseline was -185.3 μm, -155.0 μm, and -187.0 μm, respectively. Investigators described these visual and anatomic changes as comparable across the treatment groups. These week-96 findings showed similar maintenance of vision and retinal thickness reduction across dosing strategies.

In the 8 mg groups, durability was reflected in how often patients sustained or lengthened their assigned intervals. Among patients completing week 96, 88% in the 8q12 group and 83% in the 8q16 group maintained at least their randomized interval. In the same groups, 43% and 47% qualified for at least 20-week intervals, while 24% and 32% qualified for 24-week intervals. Dosing intervals in the aflibercept 8 mg groups were modified using defined criteria.

Safety reporting was limited to ocular treatment-emergent adverse events in the study eye, which occurred in 37.1% to 45.4% of patients across groups. The incidence was described as similar across treatment arms. Over 96 weeks, aflibercept 8 mg at extended intervals was associated with maintained visual and anatomic improvements, fewer injections, and similar ocular treatment-emergent adverse event incidence versus aflibercept 2 mg every 8 weeks.