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. 

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.