Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced the first presentation of two-year (96 weeks) results from the pivotal PHOTON trial of aflibercept 8 mg with 12- and 16-week dosing regimens, compared to Eylea (aflibercept) injection, in diabetic macular edema (DME) patients. 

The results were presented at the annual American Society of Retina Specialists meeting.

In June, the FDA issued a Complete Response Letter for an aflibercept 8 mg Biologics License application due to an ongoing review of inspection findings at a third-party filler. 

"Maintaining two years of vision and anatomic improvements with as few as three or four injections per year, while not compromising safety, is impressive and could make a meaningful difference in the lives of the patients we treat," said Diana Do, the trial investigator.

The 658-subject 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 was 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 last month.

89% of patients maintained ≥12-week dosing intervals, compared to 93% through one year.

84% maintained ≥16-week dosing intervals, compared to 89% maintaining a 16-week dosing interval through one year, among those randomized at baseline to a 16-week dosing interval.

44% met the criteria for ≥20-week dosing intervals at week 96, including 17% and 27% who were eligible for 20- and 24-week dosing intervals, respectively.

Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG (OTC: BAYRY), with Regeneron sponsoring the PHOTON trial. 

Price Action: REGN shares are down 0.22% at $744.49 on the last check Monday.