Aflibercept 8 mg meets primary endpoints in two global pivotal trials for DME and wAMD, with a vast majority of patients maintained on 12- and 16-week dosing intervals

The PHOTON trial in DME and the PULSAR trial in wAMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the Eylea 8-week dosing regimen. In these trials, the safety of aflibercept 8 mg was consistent with the established safety profile of Eylea. Regeneron and Bayer will submit these data to regulatory authorities in countries around the world.

"These pivotal aflibercept 8 mg trials demonstrated that nearly 90% of patients with diabetic macular edema and almost 80% of patients with wet age-related macular degeneration were able to maintain a 16-week dosing regimen," said David Brown, M.D., FACS, Director of Research at Retina Consultants of Texas in the U.S. and a trial investigator. "These unprecedented durability data coupled with a safety profile consistent with that of Eylea support aflibercept 8 mg as a potential new standard-of-care in these diseases."

PHOTON (N=658) and PULSAR (N=1,009) are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. At 48 weeks, greater than 90% of patients in all dosing groups in both trials completed the treatment period.