An FDA target action date of August 19, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for Eylea HD (aflibercept) injection 8mg for priority review.

EYLEA HD ® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and ...

If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are ...

The incidence of mild intraocular inflammation (IOI) in the real world occurs more frequently after intravitreal injection of ...

The FDA has granted Priority Review status to Regeneron’s and Bayer’s supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The application seeks to expand use ...

3 The trial evaluated the efficacy of high-dose aflibercept injection of 8 mg in patients with wet AMD. The trial found that visual gains and anatomic improvements lasted through 2 years although ...

Regeneron Pharmaceuticals has announced the U.S. FDA's acceptance for Priority Review of the supplemental Biologics License Application for EYLEA HD (aflibercept) Injection 8 mg, which ...

According to the letter, the FDA did not agree with the proposition to include additional extended dosing intervals greater than 16 weeks. The Food and Drug Administration (FDA) has issued a ...

EYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and ...