FDA approves sBLA for Eylea with 12 week dosing schedule for "wet" age related macular degeneration. Regeneron + Bayer HealthCare.

Regeneron Pharmaceuticals, Inc. announced that the FDA has approved a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase III VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed).

These data are now included inthe updated Eylea label. Eylea is also approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.