Regeneron announced that the FDA has approved a supplemental Biologics License Application for Eylea (aflibercept) injection in patients with wet age-related macular degeneration (AMD). The application was based on second-year data from the phase 3 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 in the updated EYLEA label.
“We are pleased that the FDA has approved an updated label for Eylea,” George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, said in a company news release. “Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicans make the most informed choices in treating patients suffering from wet age-related macular degeneration.”
Eylea is also approved in wet AMD for every 4- or 8-week dosing intervals after three initial monthly doses.