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Ista announces positive preliminary results from phase 3 trial of once-daily bromfenac
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IRVINE, Calif. — Ista Pharmaceuticals has announced positive preliminary phase 3 results from the company's confirmatory clinical trial of a once-daily formulation of bromfenac sodium ophthalmic solution for reducing ocular inflammation and pain after cataract surgery, according to a press release.
The multicenter, randomized, double-masked, parallel-group, phase 3 study, which enrolled 299 patients who underwent cataract surgery in one eye, randomly assigned patients to receive either once-daily Xibrom (bromfenac ophthalmic solution 0.09%) or placebo. Pain was assessed at 1 day postop, and ocular inflammation was assessed at 15 days postop.
According to the release, ocular inflammation and ocular pain results both achieved statistical significance, confirming the safety profile currently ascribed to the twice-daily Xibrom formulation.
There were no serious ocular or systemic adverse events, the release said.
By confirming the safety and efficacy of the once-daily formulation, the current study substantiates Ista's December 2008 announcement of integrated results from an identical phase 3 trial of the once-daily bromfenac sodium ophthalmic solution formulation.
Once the full data set has been analyzed, Ista plans to file a supplemental New Drug Application with the U.S. Food and Drug Administration by the end of the year.