FDA pushes back action date for priority review of wet AMD treatment
TARRYTOWN, N.Y. - The U.S. Food and Drug Administration has extended its estimated completion date for the priority review of Regeneron's Eylea Biologics License Application by 3 months, according to a company press release.
The FDA implemented the extension in order to allow more time to review recent feedback regarding the chemistry, manufacturing and controls section of the license application. The new target date for completing the review of the license application is Nov. 18, according to the release.
Eylea, which is also known as VEGF Trap-Eye (aflibercept ophthalmic solution), is an intravitreal injection designed to treat neovascular age-related macular degeneration.