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FDA committee recommends approval of wet AMD treatment

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TARRYTOWN, N.Y. — The U.S. Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has recommended approval of Eylea for the treatment of wet age-related macular degeneration, according to a news release from Regeneron Pharmaceuticals.

The FDA made its recommendation on June 17.

The regimen under review is 2 mg of Eylea, also known as VEGF Trap-Eye (aflibercept ophthalmic solution, Regeneron Pharmaceuticals) every 8 weeks following three initial doses every 4 weeks, according to the release.

"The positive recommendation by the advisory committee is an important step toward providing wet AMD patients with a new treatment option that could potentially reduce the burden that exists with current therapies," George D. Yancopoulos, MD, PhD, president of Regeneron Research Laboratories, said in the release. "We look forward to continuing to work with the FDA as it completes its evaluation of the Eylea [Biologics License Application]."

The committee based its recommendation on results of two phase 3 clinical trials, VIEW 1 and VIEW 2. According to the release, all regimens of aflibercept ophthalmic solution met the primary endpoint of statistical non-inferiority with Lucentis (ranibizumab, Genentech) 0.5 mg monthly dosing, the current standard of care. The drug maintained or improved vision over 52 weeks at a rate comparable to ranibizumab, the release said.

In addition, aflibercept ophthalmic solution offered a safety profile comparable to ranibizumab; the most common ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage and vitreous floaters.

The FDA will consider the recommendation of approval and Regeneron's Biologics License Application; the recommendation is non-binding. Regeneron's application received Priority Review designation in February; the FDA is expected to render a decision on the application by Aug. 20.

Regeneron holds exclusive U.S. rights to aflibercept ophthalmic solution. Bayer HealthCare will market the drug outside the U.S., and the companies will equally share the profits from sales outside the U.S., the release said.