Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve extending the dosing intervals for Eylea HD, according to a press release from Regeneron.
Eylea HD (aflibercept injection 8 mg) is currently approved for dosing intervals of every 8 to 16 weeks to treat wet age-related macular degeneration and diabetic macular edema, as well as every 8 to 12 weeks to treat diabetic retinopathy, after three initial (Read more...)