The Pharma Letter

New MHRA indication for Bayer’s Eylea

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of Eylea (aflibercept 8mg, 114.3 ...
PharmiWeb

Bayer receives MHRA authorisation for third retinal indication of Eylea® (aflibercept 8 mg) for treatment of retinal vein occlusion

The MHRA has granted marketing authorisation for Eylea® (aflibercept 8 mg) for the treatment of patients with macular oedema following retinal vein occlusion (RVO) including branch, central and ...
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 ...
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) ...
Business Insider

EYLEA HD® (aflibercept) Injection 8 mg Presentations at Angiogenesis 2026 Underscore Strength of its Clinical Profile for the Treatment of Serious Retinal Diseases

TARRYTOWN, N.Y., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced upcoming presentations from its ophthalmology portfolio and pipeline at the virtual ...
ksn.com

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 ...
Seeking Alpha

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 ...
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 ...