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Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application

TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) ...
Healio

Eylea HD

Aflibercept is used to treat certain serious eye conditions (such as macular edema/degeneration, diabetic retinopathy, retinopathy of prematurity). This medication can help preserve vision and prevent ...
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EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly ...

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 indicated ...
MedPage Today

FDA Approves First Interchangeable Biosimilars to Aflibercept for AMD

The FDA approved the first interchangeable biosimilars to aflibercept (Eylea) to treat macular degeneration, according to an announcement from the agency. As interchangeable biosimilars, ...
WPRI 12

EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications

TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD ® (aflibercept) ...
Monthly Prescribing Reference

Eylea Hd

Aflibercept 8mg (0.07mL of 114.3mg/mL); per vial; soln for oph intravitreal inj; preservative-free. A single-dose glass vial containing one Eylea HD 8 mg (0.07 mL of a 114.3 mg/mL solution); or A vial ...