Macular Degeneration Drug Eylea Approved

Drug Is a New Option for AMD, a Common Cause of Blindness

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Nov. 18, 2011 -- The FDA has approved Eylea for the treatment of the wet form of age related macular degeneration (AMD), the major cause of blindness in the elderly.

Eylea inhibits a factor that makes unwanted blood vessels grow in the retina. The blood vessels can leak blood and fluid, causing damage to the retina. Eylea blocks all forms of this factor, called VEGF, and also blocks a second similar factor.

In June 2011, an FDA advisory panel unanimously recommended approval of Eylea, previously called VEGF Trap-Eye. The generic name for Eylea is aflibercept.

"Eylea is an important new treatment option for adults with wet AMD," Edward Cox, MD, MPH, director of the FDA's Office of Antimicrobial Products, says in a news release. "It is a potentially blinding disease and the availability of new treatment options is important."

Eylea is the third AMD drug to be approved by the FDA. Macugen inhibits a single form of VEGF, while Lucentis, like Eylea, blocks all forms. All three of these AMD drugs are given by injection into the eye with a tiny needle.

Lucentis is given once every month, although some patients may need treatment only once every three months. Macugen is given every six weeks. Eylea is given once every two months after three once-a-month injections.

Lucentis, currently the preferred drug treatment for AMD, costs about $2,000 per treatment. Since Lucentis is a low-dose form of the cancer drug Avastin, some doctors prefer to treat patients with a diluted formulation of Avastin at a cost of about $50.

In clinical trials, Eylea worked as well as Lucentis. It's not yet clear what Eylea will cost, although some financial analysts predict the cost will be only slightly less than Lucentis.

Although the FDA has ruled that Eylea's benefits outweigh its risks, the drug can cause some serious side effects.

In clinical trials, the most common side effects of Eylea were bleeding in the white part of the eye at the site of injection, eye pain, cataracts, detachment of the gel part of the eye (vitreous) from the retina, floating spots in the vision, and increased pressure within the eye.

Eylea is marketed by Tarrytown, N.Y.-based Regeneron Pharmaceuticals Inc.

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SOURCES: News release, FDA.National Eye Institute web site.

FDA briefing information and transcript, Transplant and Ophthalmology Products Advisory Committee meeting, June 17, 2011.

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