Intravitreal aflibercept 8 mg in patients from Japan with diabetic macular edema: 48-week subgroup analysis of the PHOTON trial

Purpose: In the pivotal PHOTON trial of patients with diabetic macular edema (DME), aflibercept 8 mg administered every 12 (8q12) and 16 (8q16) weeks demonstrated similar visual and anatomic outcomes with no new safety signals to aflibercept 2 mg every 8 weeks (2q8). We conducted a prespecified subgroup analysis to assess the efficacy, durability, and safety of aflibercept 8 mg in the Japanese patients from PHOTON. Study design: Prespecified subgroup analysis of the Phase 3 PHOTON trial (NCT04429503). Methods: Adult patients with DME were randomized 1:2:1 to receive intravitreal aflibercept 2q8, 8q12, or 8q16 following initial monthly doses. Patients randomized to 8q12 and 8q16 were eligible for dose regimen modification. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at Week 48. Prespecified efficacy and safety outcomes at/through Week 48 are reported, segmented by Japan versus the rest of world (non-Japan). Results: In the Japan and non-Japan subgroups, respectively, mean changes in BCVA were +7.0 and +9.0 (8q12), +7.4 and +7.9 (8q16), and +8.0 and +9.4 (2q8) letters at Week 48; differences in least squares means were -0.30 and -0.64 letters between 8q12 and 2q8 and +0.17 and -1.76 letters between 8q16 and 2q8; ocular treatment-emergent adverse events were reported in 32.4% and 31.6% (8q12), 35.3% and 28.8% (8q16), and 30.0% and 27.2% (2q8) of patients. Conclusion: Improvements in BCVA at Week 48 were generally similar with aflibercept 8 mg versus 2 mg in this subgroup analysis of Japanese and non-Japanese patients with DME, suggesting that the primary findings from PHOTON may be generalized to the Japanese population.