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 ...
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

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 ...
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 ...
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) ...
WKRG

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) ...