FDA says Ista Pharmaceuticals’ eye drug Bepreve did not show serious adverse effects in tests

FDA says Ista eye drug has no serious side effects

WASHINGTON — Federal health scientists said Wednesday an anti-itching drug from eye care company Ista Pharmaceuticals did not show any serious side effects in testing on patients.

Ista is asking the Food and Drug Administration to approve its formula Bepreve to relieve itchiness caused by seasonal allergies.

In documents posted online, the FDA said no patients tested with the drug experienced a dangerous side effect. The most common side effect was a distortion of the sense of taste, which occurred in roughly 20 percent of patients. That side effect was classified as mild or moderate.

Ista studied the drug in three studies. Patients were asked to evaluate their itchiness on a scale of one to four, while physicians judged the redness of patients' eyes before and after using the formula.

FDA plans to ask a panel of experts next week whether Bepreve is safe and effective for allergic conjunctivitis. The agency is not required to follow the group's advice, though it usually does.

FDA is expected to make a decision on the drug by September.

Bepreve is one of two developmental products considered critical to Ista's business outlook. The other is an experimental topical steroid for eye infections, called T-Pred, which is also under FDA review.

Shares of Irvine, Calif.-based Ista Pharmaceuticals rose 26 cents, or 6.9 percent, to $4.05 in afternoon trading.


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