FDA Approves Higher Dose Eylea

The FDA has approved Eylea HD (aflibercept) injection 8 mg to treat patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Eylea HD is administered every four weeks for the first three months across all indications, followed by every eight to 16 weeks in wAMD and DME and every eight to 12 weeks for diabetic retinopathy.

Developed by Regeneron and Bayer, Eylea HD has a list price of $2,625 per single-use vial, according to a Regeneron statement. The company is launching Eylea HD early this week. A spokesperson said patients who have Medicare Part B will have immediate coverage for approved indications. Patients with commercial insurance are expected to have coverage in the next six months.

Eylea 2 mg is already available with a wholesale acquisition cost of $1,957.55, according to Drugs.com. In addition, Eylea is available as a 0.4 mg dose to treat retinopathy of prematurity.

wAMD occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. An estimated 1.4 million Americans have wAMD.

Diabetic retinopathy is characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. Diabetic macular edema occurs as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the United States, about 1.5 million adults are diagnosed with diabetic macular edema, while about 6 million people have diabetic retinopathy.

Peter Kaiser, M.D.

“With Eylea HD, patients with wet age-related macular degeneration or diabetic retinal disease can now receive less frequent injections after their initial monthly doses and still experience the similar visual gains, anatomic improvements and safety profile of Eylea,” Peter Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine.

Related: FDA Rejects Higher Dose of Eylea

The approval comes two months after the FDA issued a complete response letter (CRL) for the higher dose. The CRL was issued related to an ongoing review of inspection findings at a third-party filler. Regulators did not identify any issues with the Eylea 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested.

The FDA approval of the higher dose is based on the 48-week results of PULSAR and PHOTON pivotal trials evaluating Eylea HD compared with Eylea 2 mg. Both trials met their primary endpoint, with Eylea HD demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after three initial monthly doses.

The most common adverse reactions of Eylea HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.