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Injections intravitréennes d'aflibercept 8mg chez les patients atteints d'oedème maculaire diabétique: Résultats à 48 semaines de l'essai de phase 2/3 PHOTON

In the Phase 2 CANDELA trial, greater anatomic and visual improvements were achieved with intravitreal aflibercept 8 mg versus 2 mg in patients with neovascular age-related macular degeneration, with similar safety. The Phase 2/3 PHOTON trial evaluated the efficacy and safety of intravitreal aflibercept injection 8 mg versus 2 mg in patients with diabetic macular edema (DME).

PHOTON (NCT04429503) is an ongoing, double-masked, 96-week, non-inferiority trial that randomized patients with DME to receive intravitreal aflibercept 8 mg every 12 or 16 weeks after 3 monthly doses (8q12 [n=328] or 8q16 [n=163]) or aflibercept 2 mg every 8 weeks after 5 monthly doses (2q8; n=167). During Weeks 16‒48, patients in the 8q12 or 8q16 arms received aflibercept 8 mg in shorter intervals if they met prespecified dose regimen modification criteria denoting disease activity. The primary endpoint was the mean change from baseline in best corrected visual acuity (BCVA) at Week 48 (non-inferiority margin at 4 letters); the key secondary endpoint was the proportion of patients with ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score at Week 48 (non-inferiority margin at 15%). 

Mean BCVA change from baseline at Week 48 was +9.2, +8.8, and +7.9 letters with 2q8, 8q12, and 8q16, respectively (least squares mean difference: non-inferiority p<0.0001 for 8q12 vs 2q8 [95% CI: ‒2.26, 1.13]; non-inferiority p=0.0031 for 8q16 vs 2q8 [95% CI: ‒3.27, 0.39]). The proportion of patients with &ge;2-step improvement from baseline in DRSS score was 27%, 29%, and 20% with 2q8, 8q12, and 8q16, respectively (8q12 group met the non-inferiority margin of 15% [95% CI vs 2q8: ‒6.61, 10.57] whereas the 8q16 group did not [95% CI vs 2q8: ‒16.88, 1.84]). Through Week 48, 91% (8q12) and 89% (8q16) of patients maintained their original randomized dosing interval with no shortening, and in the 8 mg combined group, 93% of patients maintained a dosing interval &ge;12 weeks. Safety outcomes for intravitreal aflibercept 8 mg and 2 mg were similar through Week 48. 

Intravitreal aflibercept 8 mg met the primary efficacy endpoint in DME, demonstrating non-inferiority in BCVA versus intravitreal aflibercept 2 mg, with no new safety signals through 48 weeks. The vast majority of patients maintained extended &ge;12-week dosing (93% in 8 mg combined) and 16-week dosing (89% in 8q16). 

Overall, intravitreal aflibercept 8 mg provides greater therapeutic benefit, an expanded injection interval, and equivalent safety versus intravitreal aflibercept 2 mg in patients with DME.

This abstract is presented on behalf of the PHOTON study investigators.