FDA Sets Action Date for Eylea HD in Retinal Vein Occlusion

The FDA has accepted for priority review Regeneron’s supplemental biologics license application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The sBLA seeks approval for Eylea HD to treat patients with macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications.

The FDA's target action date is Aug. 19, 2025

Eylea 2 mg already is approved to treat patients with macular edema after retinal vein occlusion, which is a blockage in a small blood vessel that carries blood away from the retina. Retinal vein occlusion is a common cause of vision loss in adults and the second most common retinal vascular disease.

The low-dose form of Eylea is also approved to treat patients with retinopathy of prematurity (ROP), neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. Eylea HD is approved for patients with neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy.

In 2024, U.S. sales of Eylea (low dose and HD combined) were $4.77 billion. Eylea 2 mg has a list price of $1,896.25 for a single-dose glass vial. Eylea HD 8 mg has a cost of $2,625.

The sBLA is based on the QUASAR clinical program, which includes the phase 3 QUASER trial investigating Eylea HD 8 mg to treat patients with macular edema following retinal vein occlusion.

In February 2025, Regeneron reported results from this trial. QUASAR met its primary endpoint at 36 weeks, with patients treated with Eylea HD dosed every 8 weeks (after either 3 or 5 monthly doses) achieving non-inferior visual acuity gains compared to those receiving Eylea 2 mg dosed every 4 weeks. Currently, all anti-VEGF therapies approved to treat RVO are indicated for monthly dosing.

Seenu M. Hariprasad, M.D.

“Retinal vein occlusion is the second most common retinal vascular disease. However, the current treatment paradigm of monthly eye injections can make it challenging for patients to maintain their treatment plan, potentially leading to poor adherence and vision loss,” Seenu M. Hariprasad, M.D., chair of the Department of Ophthalmology and Visual Science, The University of Chicago, said in a news release in February 2025.

In QUASAR, the safety profile of the high-dose Eylea in 591 patients was similar to the 301 patients treated with Eylea 2 mg. Increased ocular pressure (5%) was the only ocular treatment-emergent adverse event that occurred in ≥5% of all Eylea HD patients, compared with 1.7% of patients who received Eylea 2 mg. The rate of intraocular inflammation was 0.5% for Eylea HD and 1.3% for Eylea 2 mg.

There are two main types of retinal vein occlusion: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). In CRVO, the buildup occurs in the eye’s central retinal vein, and in BRVO, the buildup occurs in one of the smaller branch veins. Globally, retinal vein occlusion affects more than 28 million people.

Additionally, Regeneron released three-year data for patients with wAMD treated with Eylea HD in the extension study of the phase 3 PULSAR trial. The vast majority of patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year.

Additionally, patients who switched from Eylea 2 mg to Eylea HD at the beginning of the third year were also able to maintain vision and anatomic improvements through the end of the third year, but with longer dosing intervals and fewer injections.