FDA announces eye medication has no serious side effects

Interesting story….

The AP (6/25) reports that in “documents posted online” on June 24, the FDA said that “an anti-itching drug from eye care company Ista Pharmaceuticals did not show any serious side effects in testing on patients.” Now, Ista is asking the agency “to approve its formula Bepreve [bepotastine besilate] to relieve itchiness caused by seasonal allergies.” Next week, the “FDA plans to ask a panel of experts…whether Bepreve is safe and effective for allergic conjunctivitis.” The FDA “is not required to follow the group’s advice, though it usually does.”

According to the Dow Jones Newswires (6/25, Dooren), “the agency questioned data involving another proposed eye drop, Rejena [hyaluronate sodium solution], by privately held River Plate Biotechnology, Inc. for the treatment of dry-eye disease. If approved, Rejena would be marketed by Alcon Inc.” Rejena will also “be reviewed Friday by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.” Meanwhile, “ISTA said it expects the FDA to make a final decision on whether to approve Bepreve by Sept. 12.”

The Orange County Business Journal (6/24, Reed) pointed out that although “Ista Pharmaceuticals Inc.’s proposed eye allergy drops didn’t cause serious safety problems in clinical trials,” agency “reviewers said in that in one study, 25 percent of patients treated with…Bepreve reported a taste-related side effect, such as a bitter taste or aftertaste.” Reuters (6/25, Richwine) also covers the story.


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