FDA approves Eylea HD for retinal vein occlusion

The FDA has approved Eylea HD (aflibercept) 8 mg to treat patients with macular edema following retinal vein occlusion (RVO) with dosing of up to every 8 weeks after an initial monthly dosing period.

Retinal vein occlusion is a blockage in a blood vessel that carries blood away from the retina. Symptoms include blurry vision or vision loss in one eye. It can lead to serious complications such as swelling or bleeding in your eye. Retinal vein occlusion is the second most common cause of vision loss, after diabetic retinopathy.

“Eylea HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies,” said George D. Yancopoulos, M.D., Ph.D., co-founder, president, and chief scientific officer at Regeneron, which developed Eylea and Eylea HD.

The approval is based on data from the phase 3 QUASAR trial that evaluated the efficacy and safety of Eylea HD compared with Eylea 2 mg in patients with retinal vein occlusion.

The study met its primary endpoint at 36 weeks, demonstrating non-inferior visual acuity gains with Eylea HD patients dosed every 8 weeks compared with Eylea 2 mg dosed every 4 weeks. The Eylea HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. 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.

In the QUASAR trial, the most common adverse reactions for those treated with Eylea HD were increased intraocular pressure, blurred vision, cataracts, conjunctival hemorrhage, ocular discomfort/eye pain/eye irritation, and vitreous detachment.

The FDA also approved Eylea HD for 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, diabetic macular edema, diabetic retinopathy, and retinal vein occlusion

Additionally, Eylea HD is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

Regeneron officials have also provided an update on the Eylea HD pre-filled syringe. The company continues to coordinate with Catalent Indiana (part of Novo Nordisk A/S) as it works to resolve the outstanding issues identified from a July 2025 FDA general site inspection. Regeneron also plans to submit to the FDA an application to include an alternate pre-filled syringe manufacturing filler by January 2026.

Eylea 2 mg has a list price of $1,942.33 for a single-dose vial or the prefilled syringe. Eylea HD 8 mg has a cost of $ $2,731.05.

In the third quarter of 2025, Regeneron reported U.S. net sales of Eylea HD increased 10% to $431 million; total Eylea HD and Eylea U.S. net sales decreased 28% to $1.11 billion for several reasons, including a lower net selling price, competition from compounded bevacizumab, and the continued transition of patients to Eylea HD.

Officials noted that the company reached a resolution of its patent infringement litigation related to Sandoz, Formycon, and Celltrion for biosimilars of Eylea 2 mg biosimilar. The biosimilars will not launch until the fourth quarter of 2026.

Related: Eylea HD Provides Vision Gains and Longer Dosing Intervals in Real-World Analysis | AAO 2025

Treatment-naive patients with either wet age-related macular degeneration or diabetic macular edema get the most benefit from Eylea HD, with a gain of four or five letters in a test of visual acuity, according to a real-world study that was presented at the annual American Academy of Ophthalmology meeting in October 2025.