FDA

Eylea HD OK’d for post-RVO macular edema, monthly dosing added across indications

November 27, 2025

On November 19, 2025, FDA approved Eylea HD (aflibercept) injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.

The agency also approved an every 4-week (monthly) dosing option for some patients who may benefit from resuming this dosing schedule across approved indications: wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.

Efficacy

Approval for RVO was based on data from the phase 3 QUASAR trial (NCT05850520) that evaluated the efficacy and safety of Eylea HD compared with Eylea (aflibercept injection 2 mg) in patients with RVO. QUASAR met its primary endpoint at 36 weeks, with Eylea HD patients dosed every 8 weeks (after either 3 or 5 monthly doses) achieving non-inferior visual acuity gains compared with those receiving Eylea dosed every 4 weeks. Eylea HD results were consistent across patients with branch RVOs, and those with central retinal or hemiretinal vein occlusions.

Safety

In RVO, the most common adverse reactions reported in ≥3% of patients treated with Eylea HD were intraocular pressure increased, vision blurred, cataract, conjunctival hemorrhage, ocular discomfort/eye pain/eye irritation, and vitreous detachment.

Recommended dose

Eylea HD is approved with dosing intervals of every 8 weeks for patients with RVO (following 3 to 5 initial monthly doses). In clinical trials, some Eylea HD patients didn't maintain a response with extended dosing intervals after successful response to initial monthly doses; these patients may benefit from resuming every 4-week dosing.

Sources:

Eylea HD (aflibercept) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761355s010lbl.pdf revised November 2025. Accessed November 26, 2025.

Eylea HD® (aflibercept) injection 8mg approved by FDA for the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing across approved indications. [News release]. 2025. https://www.globenewswire.com/news-release/2025/11/19/3191435/0/en/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.html