FDA pins approval on Regeneron eye drug Eylea

Regeneron ($REGN) is wrapping up the week with a big victory. U.S. regulators have given market approval to the Tarrytown, NY-based company's Eylea for treating a neurovascular form of wet age-related macular degeneration, the most common cause of blindness in adults older than 65 in the U.S. and Europe. It's an approval that was highly expected after an FDA advisory committee unanimously backed the drug in June.

The drug, also called VEGF Trap-Eye, was approved for use every month for the first three months of treatment followed by injections every 8 weeks. This makes the drug the first FDA-approved treatment for wet-AMD that can be given less frequently than once per month, according to the company. The less frequent dosing is expected to be a competitive advantage over Roche's existing therapy, Lucentis, which is recommended for use once every month. Eylea's big competition, however, is another Roche product, the cancer drug Avastin, which is used off-label in small doses to treat AMD and has been a more popular option than the more expensive Lucentis. The Wall Street Journal cited analysts who estimated Avastin is used to treat more than two-thirds of AMD cases.

Eylea showed in two late-stage clinical trials that its efficacy in patients getting injections of the drug every 8 weeks was clinically equivalent to patients getting Lucentis in the more frequent monthly doses. The drug blocks the new blood vessel formation observed in patients with wet AMD by inhibiting a vascular growth factor know as VEGF-A. The most common side effects of the drug included conjunctival hemorrhage, eye pain and intraocular pressure, according to the company.

"This approval is an important step forward for Regeneron and for patients suffering with wet AMD,"  Regeneron CEO Leonard Schleifer said in a statement. "Now that Eylea is approved, we plan to make Eylea available to patients within the next few days."

Regeneron controls exclusive rights to Eylea in the U.S. and has partnered with Bayer Healthcare, which will handle marketing of the drug in the rest of the world. Bayer filed paperwork for approval of the drug in Europe in June.

- here's the release
- get more from the FDA's statement
- see the Wall Street Journal's coverage

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