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Once-daily bromfenac enters phase 3 trials

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IRVINE, Calif. — An anti-inflammatory agent already marketed for twice-daily dosing for the treatment of post-cataract surgery pain has begun trials for once-daily dosing, the drug’s marketer said in a release.

ISTA’s Xibrom (bromfenac ophthalmic solution) will enroll about 350 patients in a multicenter phase 3 trial for the treatment of pain and inflammation following cataract surgery, the company said. ISTA expects the trials to conclude by the end of 2006, with preliminary results available in early 2007.

Xibrom is a topical non-steroidal anti-inflammatory solution for the treatment of ocular inflammation and pain following cataract surgery. Senju Pharmaceuticals has marketed the twice-daily formulation in Japan since 2000; ISTA acquired U.S. marketing rights to the drug in 2002.

Company executives said they hope the once-daily formulation will help improve patient compliance while maintaining efficacy.