The Pharma Letter

Third retinal indication for Eylea 8mg approved in Europe

The European Commission has granted marketing authorization for Eylea 8mg (aflibercept 8mg, 114.3mg/ml solution for injection ...
Nasdaq

EU Approves Bayer's Eylea 8 Mg For Extended 6-Month Dosing In Retinal Diseases

(RTTNews) - Bayer (BAYZF.PK, BAYRY.PK, BYR.L), a German pharmaceutical and life sciences major, announced that the European Commission has granted a label extension in the European Union for Eylea 8 ...
The Financial

Bayer Submits Aflibercept Solution for Intravitreal Injection for the Treatment of Myopic Choroidal Neovascularization in the EU

The FINANCIAL — Bayer HealthCare has submitted an application for marketing authorization of aflibercept solution for intravitreal injection for the treatment of myopic choroidal neovascularization ...
Pharmabiz

European Commission grants marketing approval for Eylea 8 mg to treat macular edema following RVO, including branch, central and hemiretinal vein occlusion

European Commission grants marketing approval for Eylea 8 mg to treat macular edema following RVO, including branch, central and hemiretinal vein occlusion: Berlin Monday, January ...
Nasdaq

EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting

EYLEA HD led to improved vision with extended dosing intervals, achieving non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 ...
FOX40 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 ...
Seeking Alpha

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) ...
Reuters

Bayer wins EU watchdog's endorsement for longer Eylea treatment intervals

May 23 (Reuters) - German drugmaker Bayer (BAYGn.DE), opens new tab on Friday won an endorsement by the European Medicines Agency to extend the intervals between shots of its anti-blindness treatment ...
WTEN

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 ...
Seeking Alpha

Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA® (aflibercept) Injection

TARRYTOWN, N.Y., Oct. 21, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN) today announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA ® ...
WJHL-TV

EYLEA® (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA

TARRYTOWN, N.Y., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA ® (aflibercept) ...