Aflibercept 8 Mg in DME: 96-Week Photon Trial Results

Key Takeaways

• Week 96 visual gains were broadly similar across groups, with mean best-corrected visual acuity improvement ranging from 7.5 to 8.8 letters.
• The 8 mg regimens were associated with fewer active injections, and 88% and 83% of week 96 completers maintained at least 12-week or 16-week intervals.
• Central retinal thickness improved across arms, and ocular treatment-emergent adverse events in the study eye occurred at similar rates.

In the PHOTON trial, adults with center-involved diabetic macular edema receiving aflibercept 8 mg every 16 weeks averaged about 8 active injections through week 96, compared with nearly 14 in the aflibercept 2 mg every-8-week group, while best-corrected visual acuity gains remained similar across groups. The randomized 8 mg arms paired extended dosing intervals with preserved visual improvement over 96 weeks.

PHOTON was a randomized, double-masked, 96-week, noninferiority phase 2/3 trial in adults aged at least 18 years with center-involved diabetic macular edema and BCVA of 78 to 24 letters. Patients were randomized 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. In the aflibercept 8 mg groups, dosing intervals were modified using protocol-defined criteria. The 96-week update followed the earlier 48-week comparison and focused on efficacy, durability, and ocular safety.

At week 96, mean BCVA 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 in the same groups. Visual and anatomic outcomes were broadly similar across dosing strategies.

Overall, 534 of 658 treated patients completed week 96. Mean active injections through week 96 were 9.5 in 8q12, 7.8 in 8q16, and 13.8 in 2q8. Both 8 mg regimens had lower active injection counts than the fixed every-8-week comparator over the full follow-up. Among week 96 completers, 43% of 8q12 and 47% of 8q16 qualified for at least 20-week intervals, and 24% and 32% qualified for 24-week intervals by week 96. The durability findings reflected reduced treatment frequency over long-term follow-up.

Ocular treatment-emergent adverse events in the study eye were similar across groups, with incidence ranging from 37.1% to 45.4%. The investigators concluded that aflibercept 8 mg at extended intervals maintained visual and anatomic improvements, with similar ocular safety and fewer injections over 96 weeks than aflibercept 2 mg every 8 weeks.