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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 ...
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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. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD ® (aflibercept) ...
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EYLEA HD (aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer ...
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EYLEA® HD (aflibercept) Injection 8 mg Data Presentations at AAO Reinforce Efficacy and Safety Profile in Wet Age-related Macular Degeneration and Diabetic Macular Edema

Long-term data and subgroup analyses from pivotal EYLEA HD clinical program highlight durability of visual improvements and consistent safety across extended dosing intervals and patient ...
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Regeneron's SLBA For EYLEA HD Injection 8 Mg Gets Acceptance From FDA For Priority Review

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN), Thursday announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for ...
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EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for ...