(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) reported that the primary endpoints were met in two trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema and wet age-related macular degeneration. The PHOTON trial in DME and the PULSAR trial in wAMD both showed that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen.
These aflibercept 8 mg trials showed 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. 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. Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG.
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