Regeneron announces top-line, two-year data for aflibercept 8 mg PHOTON trial

Regeneron Pharmaceuticals announced top-line, two-year data for aflibercept 8 mg from the pivotal PHOTON trial in patients with diabetic macular edema, or DME. During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals after three initial monthly doses and were able to shorten or extend dosing intervals if pre-specified criteria were met. The longer-term data among aflibercept 8 mg patients who completed the trial demonstrated that the vast majority of patients were able to maintain or further extend these dosing intervals through two years with: 89% maintaining greater than or equal to12-week dosing intervals through two years, compared to 93% through one year; 83% maintaining greater than or equal to16-week dosing intervals through two years, compared to 89% maintaining a 16-week dosing interval through one year; 43% meeting the criteria for greater than or equal to20-week dosing intervals by week 96, including 16% and 27% who were eligible for 20- and 24-week dosing intervals, respectively. 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, and the two-year data from both PHOTON and PULSAR are planned for presentation at an upcoming medical meeting. “The aflibercept 8 mg clinical trial program is the first to demonstrate that patients with diabetic macular edema can immediately be treated with every 12- or 16-week dosing after their initial monthly doses and experience lasting vision control. With these two-year results, Regeneron continues to raise the bar in clinical advancements for retinal treatments and remains committed to pursuing groundbreaking innovations in ophthalmology,” said George Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Eylea.