## FDA Expands Approval of Eylea HD for RVO and wAMD dosing

The FDA has approved 8-mg aflibercept injection (Eylea HD; Regeneron, Bayer Healthcare) for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing following an initial monthly dosing period. additionally, an every 4-week dosing option for some patients who may benefit from resuming the dosing schedule was approved for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.¹

< Aflibercept is a vascular endothelial growth factor inhibitor that had its efficacy and safety profile established by 16 clinical trials.It is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including DME, DR, macular edema following RVO, and wAMD.^1,2

This approval for the treatment of RVO is based on data from QUASAR (NCT05850520)³a global, double-masked, active-controlled phase 3 trial evaluating the efficacy and safety of the 8 mg aflibercept injection in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiret

EYLEA HD® Receives FDA Approval for Expanded Use in Retinal Diseases

The U.S. Food and Drug Governance (FDA) approved EYLEA HD® (aflibercept) injection 8 mg for the treatment of diabetic retinopathy, diabetic macular edema (DME), retinal vein occlusion (RVO), and age-related macular degeneration (AMD).This expanded approval allows for less frequent injections, potentially improving convenience for patients.

Previously approved for wet AMD, mDME, and RVO, EYLEA HD® now offers a treatment option for a broader range of patients with vision-threatening retinal conditions. Clinical trials demonstrated that EYLEA HD® achieved statistically notable gains in vision and reduced disease activity with extended dosing intervals compared to the original EYLEA formulation.

Specifically, the Phase 3 trials for RVO showed improved vision with extended dosing intervals. The trials for DME and wet AMD demonstrated non-inferiority to the original EYLEA, while also allowing for less frequent injections. This reduction in injection frequency can substantially improve the patient experience and reduce the burden of treatment.

EYLEA HD® works by inhibiting vascular endothelial growth factor A (VEGF-A), a protein that contributes to the growth of abnormal blood vessels in the eye and leakage, both of which can cause vision loss. By blocking VEGF-A, EYLEA HD® helps to stabilize blood vessels and reduce swelling in the retina.

Sources:

1. Regeneron. EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for Treatment of Diabetic retinopathy, diabetic Macular edema, Retinal Vein Occlusion and Age-Related Macular Degeneration. News release. November 21, 2025 09:58:06. https://newsroom.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-approved-fda-treatment
2. Regeneron. EYLEA HD® (aflibercept) Injection 8 mg Phase 3 Trial Meets Primary Endpoint Showing Improved Vision with Extended Dosing Intervals in Patients with macular Edema following Retinal vein Occlusion. News release. December 17, 2024. Accessed November 21, 2025.