89% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals through two years

Of those assigned to a 16-week dosing regimen at baseline, 83% maintained ≥16-week dosing intervals through two years

Many patients met the extension criteria for even longer dosing intervals, including 43% for ≥20-week intervals and 27% for 24-week intervals

Visual gains and safety of aflibercept 8 mg remained consistent with the established profile of EYLEA®(aflibercept) 2 mg Injection

TARRYTOWN, NY, June 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced top-line, two-year (96 weeks) data for aflibercept 8 mg from the pivotal PHOTON trial in patients with diabetic macular edema (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 ≥12-week dosing intervals through two years, compared to 93% through one year (48 weeks)
• 83% maintaining ≥16-week dosing intervals through two years, compared to 89% maintaining a 16-week dosing interval through one year
• 43% meeting the criteria for ≥20-week dosing intervals by week 96, including 16% and 27% who were eligible for 20- and 24-week dosing intervals, respectively

“The two-year PHOTON results for aflibercept 8 mg in patients with diabetic macular edema are extremely compelling,” said Jeffrey Heier, M.D., Director of the Retina Service and Retina Research at Ophthalmic Consultants of Boston and a trial investigator. “To be able to rapidly achieve extended dosing intervals without any sacrifice of vision gains over two years is a tremendous benefit in the treatment of diabetic macular edema.”

“The two-year PHOTON results certainly exceeded my expectations and indicate that the majority of patients may eventually be able to control their diabetic macular edema with as few as two or three aflibercept 8 mg injections per year, if approved by regulatory authorities, with similar excellent visual gains and a safety profile consistent with EYLEA given every 8 weeks,” said David M. Brown, M.D., FACS, Director of Research at Retina Consultants of Texas and a trial investigator. “Reducing the treatment burden in patients with diabetic macular edema is a critical unmet need, and the two-year PHOTON results reinforce the potential of aflibercept 8 mg to become the standard of care for the treatment of diabetic macular edema.”

PHOTON (N=658) is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg 12-week (n=328) and 16-week (n=163) dosing regimens after three initial monthly doses compared to an 8-week dosing regimen for EYLEA (aflibercept) Injection (n=167) after five initial monthly doses. In addition to the vast majority of trial patients maintaining extended dosing intervals through two years, visual gains for aflibercept 8 mg remained consistent with the first year of the trial.

BCVA: best corrected visual acuity; LS: least squares; SE: standard error; LOCF: last observation carried forward^Based on patients completing week 48 or 96 in the trial*Non-inferiority p-value: p