Nasdaq

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 ...
WWLP-22News

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) ...
Business Insider

EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA Extended dosing intervals with EYLEA HD have the potential to ...
KRON4 News

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 ...
Nasdaq

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 ...
Yahoo

European regulator endorses high-dose version of Bayer eye drug Eylea

FRANKFURT (Reuters) -Bayer said on Friday that the European Medicines Agency recommended approval of a higher dose version of eye drug Eylea for treatment of a leading cause of blindness among the ...