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ISTA to start phase 3 clinical trials of once-daily Xibrom for ocular pain, inflammation
By Lisa Kerner
Erie, Pa., May 30 - ISTA Pharmaceuticals, Inc. said it is beginning two randomized, double-blind, placebo-controlled multi-center phase 3 clinical trials of a new proprietary once-daily formulation of Xibrom (bromfenac ophthalmic solution) for the treatment of pain and inflammation following cataract surgery.
The Food and Drug Administration has approved twice-daily Xibrom for the treatment of ocular inflammation and reduction of ocular pain following cataract surgery, according to a company news release.
About 350 patients are expected to enroll in the trials, which are designed to investigate the safety, tolerability and efficacy of once-daily Xibrom for the treatment of post-operative ocular pain and inflammation in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.
ISTA expects to conclude the trials in the fourth quarter, with results available in early 2007.
The company acquired the U.S. marketing rights for the twice-daily non-steroidal anti-inflammatory solution in May 2002 from Senju Pharmaceuticals Co. Ltd.
In two previously completed pivotal phase 3 clinical studies, ISTA said a statistically significant proportion of the 527 patients treated with Xibrom twice-daily formulation achieved complete absence of ocular inflammation compared to those patients who received a placebo.
In addition, 75% of Xibrom-treated patients were pain-free within two days of being treated, while 93% of patients were pain-free within six days of treatment.
ISTA is an Irvine, Calif., specialty pharmaceutical company focused on ophthalmic products.
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