“Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD ® (aflibercept) Injection 8 mg; uncertainty of the ...

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.

Regeneron is evaluating the FDA’s decision ... achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently ...

but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME and DR. At Regeneron, we relentlessly pursue ...

Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with ...