Irvine, CA—ISTA Pharmaceuticals Inc. plans to file a supplemental new drug application with the FDA later this year based on preliminary results and pending further analyses of a phase III trial of its once-daily formulation of bromfenac sodium ophthalmic solution (Xibrom). If approved, this formulation of the topical non-steroidal anti-inflammatory drug (NSAID) would become the only once-daily treatment for ocular pain and inflammation after cataract surgery.
The multicenter study compared the drug with placebo in more than 500 patients who underwent cataract surgery. The once-daily formulation contains a higher concentration of bromfenac compared with the original twice-daily product, but its safety profile appears to be consistent with the currently marketed formulation.
“The once-daily formulation will provide the most potent and conveniently dosed ophthalmic NSAID to patients undergoing cataract surgery,” said Vicente Anido Jr., PhD, ISTA president and chief executive officer. “As studies show time and again, less-frequent dosing improves patient compliance, and we believe patients will benefit significantly should [bromfenac] once-daily receive FDA approval.”
Dr. Anido said that the company will announce final results of its research on the drug at a peer-reviewed forum.
Bromfenac, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for the drug in 2002 and launched it in the United States in 2005. Bromfenac is the first and only FDA-approved twice-daily NSAID for inflammation and pain following cataract surgery.