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Ista’s Eye Drug Is Free Of Serious Side Effects, Says FDA

Food and Drug Administration said on Wednesday that Irvine-based Ista Pharmaceuticals Inc.’s proposed anti-itching drug did not show any serious side effects when tested on patients. Ista is asking the federal body to approve its proposed eye allergy drops called Bepreve to relieve itchiness caused by seasonal allergies.

FDA reviewers tested with Bepreve experienced no dangerous side effects, apart from taste-related common side effects like distortion of the sense of taste or bitter taste, reported nearly 25 percent of patients. FDA classified the side effect as mild or moderate.

FDA plans to call an advisory panel this week to consider whether Bepreve is safe and effective for allergic conjunctivitis. FDA is likely to make a decision on the drug by September this year. Reportedly, Ista acquired the rights to Bepreve in 2006 from Japan’s Senju Pharmaceutical Co. Ltd. The former also holds rights to develop a formulation of Bepreve for nasal allergies.

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