ISTA says daily Xibrom eye drops met goal in study
IRVINE, Calif. — ISTA Pharmaceuticals Inc. on Wednesday reported successful late-stage clinical trial results for Xibrom QD, a new once-per-day eye drug.
The company said Xibrom QD eye drops were significantly better than a placebo at eliminating eye inflammation 15 days after cataract surgery. The drug also achieved a secondary goal of eliminating eye pain one day after surgery. The drug is a once-per-day version of Xibrom, a drug that is already on the market but is intended to be used twice a day.
The trial included 299 patients who had cataract surgery on one eye.
ISTA said it expects to file for Food and Drug Administration approval of Xibrom QD by the end of the year. In late 2008, the FDA asked ISTA to run a third late-stage study of the drug to confirm results from previous trials.
ISTA acquired the U.S. marketing rights to Xibrom in 2002 and launched the product in 2005. The company said sales in the first half of 2009 were $33.8 million, making the drug the best selling anti-inflammatory eye drops in the U.S.
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