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At ARVO 2023, Do discusses the benefit of aflibercept 8 mg for DME in the phase 2/3 PHOTON trial, demonstrating non-inferiority in BCVA vs aflibercept 2 mg and no new safety concerns.
Aflibercept 8 mg met the primary efficacy endpoint in patients with diabetic macular edema (DME) in the PHOTON trial, demonstrating noninferiority to Aflibercept 2 mg, and showing no new safety signals through 48 weeks.
According to the data, most patients maintained extended ≥12-week dosing (93% in 8 mg-combined) and 16-week dosing (89%), with the investigative team suggesting aflibercept provides greater therapeutic benefit and an expanded injection interval.
The research was presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting in New Orleans, Louisiana
“I think the robust data set from both the PHOTON study of Aflibercept 8 mg in DME and the PULSAR study of Aflibercept 8 mg in neovascular age-related macular degeneration (AMD) are very promising, because both studies met the primary endpoint, showing efficacy and also showing excellent safety,” Diana V. Do, MD, Byers Eye Institute, Stanford University School, told HCPLIve at ARVO 2023. “I think these data sets which are large and extensive in global clinical trials show that there is a promise that 8 mg Aflibercept will be a useful treatment option for patients once it is available.”
The PHOTON trial is an ongoing, double-masked, 96-week, non-inferiority trial that randomized patients with DME to receive aflibercept 8 mg every 12 (8q12; n = 328) or 16 weeks (8q16; n = 163) after 3 monthly doses or aflibercept 2 mg every 8 weeks after 5 monthly doses (2q8; n = 167). During Weeks 16 to 48, those 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 for the trial was the mean change from baseline in BCVA at Week 48 (noninferiority margin at 4 letters), with the key secondary endpoint being the proportion of patients with ≥2-step improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48 (noninferiority margin at 15%). Additionally, the mean change from baseline in total fluorescein leakage area at Week 48 per reading center was evaluated as an exploratory endpoint.
Upon analysis, investigators found the mean 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 <.0001 for 8q12 vs. 2q8 [95% CI, -2.26 to 1.13]; non-inferiority P = .0031 for 8q16 vs. 2q8 [95% CI, -3.27 to 0.39]).
Data showed the proportion of patients with ≥2-step improvement from baseline in DRSS score was 27%, 29%, and 20% with 2q8, 8q12, and 8q16, respectively. Investigators noted the 8q12 group met the non-inferiority margin of 15% (95% CI vs. 2q8, -6.61 to 10.57), but the 8q16 group did not (95% CI vs. 2q8, -16.88 to 1.84).
Through Week 48, the analysis showed 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 ≥12 weeks. Additionally, the mean change from baseline in total fluorescein leakage area at Week 48 was -9.2, -13.9, and -9.4 mm2 with 2q8, 8q12, and 8q12, respectively. Investigators noted the safety outcomes for aflibercept 8 mg and 2 mg were similar through Week 48.
For more perspective on the above findings, watch our interview with Dr. Do at ARVO 2023 here.
Disclosures: Diana V. Do, MD reports having received financial support from Boehringer Ingelheim, Genentech, Kriya, and Regeneron Pharmaceuticals Inc.