Regeneron presents aflibercept 8 mg two-year results from pivotal PHOTON trial

Regeneron Pharmaceuticals announced the first presentation of positive two-year results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA Injection, in patients with diabetic macular edema. The results were presented at the American Society of Retina Specialists annual meeting. PHOTON is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg extended dosing intervals compared to EYLEA. Patients receiving aflibercept 8 mg were initially randomized to either 12- or 16-week dosing intervals compared to an 8-week dosing regimen for EYLEA after five initial monthly doses. During the trial, patients receiving aflibercept 8 mg could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Patients were only able to extend their dosing intervals in the second year by 4-week increments up to 24-weeks, if pre-specified criteria were met. The PHOTON trial met its primary endpoint last year with aflibercept 8 mg patients achieving clinically equivalent vision gains to EYLEA, with approximately 90% maintaining 12- and 16-week dosing regimens through the first year. Through two years, the mean number of injections administered were 9.5 for the 12-week aflibercept 8 mg group, 7.8 for the 16-week aflibercept 8 mg group, and 13.8 for the EYLEA group, with the vast majority of aflibercept 8 mg patients maintaining extended dosing intervals as first shared in June 2023. The safety of aflibercept 8 mg continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for DME. The two-year data from the pivotal PULSAR trial for aflibercept 8 mg in wet age-related macular degeneration are expected in the third quarter of 2023.