The FDA has approved a supplemental biologics license application for a 12-week dosing schedule of Eylea injection in wet age-related macular degeneration patients, Regeneron announced in a press release.
The FDA previously issued a complete response letter to Regeneron regarding the sBLA, which is based on data from the phase 3 VIEW 1 and 2 trials, in which wet AMD patients received Eylea (aflibercept) injections at least every 12 weeks, with additional doses as needed.
“We are pleased that the FDA has approved an updated label for Eylea,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in the release. “Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration.”
Eylea was already approved for dosing intervals of every 4 weeks or every 8 weeks, after three initial monthly doses, for wet AMD.