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FDA advisory committee recommends approval of Bepreve for allergic conjunctivitis

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IRVINE, Calif. - The U.S. Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee has recommended the approval of bepotastine besilate ophthalmic solution 1.5% for treating ocular itching due to allergic conjunctivitis.

Bepreve (bepotastine besilate ophthalmic solution 1.5%, Ista Pharmaceuticals) is a nonsedating, highly selective antagonist of the histamine receptor, according to an Ista press release. It stabilizes mast cells and suppresses eosinophils migration into inflamed tissues. The drug would be available as an eye drop treatment.

"The committee's vote supports our belief that Bepreve provides a safe and effective treatment for ocular itching associated with allergic conjunctivitis," Vicente Anido Jr., PhD, president and chief executive officer of Ista Pharmaceuticals, said in the release. "We will continue to work closely with the FDA as we approach the September 12th action date."

Although the FDA is not required to adhere to the panel's recommendations, in most cases it does.