Once-daily drug as safe as original formula

Lrvine, CA-ISTA Pharmaceuticals Inc. said its bromfenac sodium ophthalmic solution (Xibrom) once-daily formulation produced highly statistically significant results in its phase III clinical trials.

The multicenter studies evaluated the drug versus placebo in more than 500 patients who underwent cataract surgery. Preliminary results of the trials demonstrated the drug was highly statistically significant in treating postoperative ocular pain and inflammation associated with cataract surgery. Preliminary analysis shows the safety profile of the once-daily formulation is consistent with the original twice-daily product. If approved by the FDA, the new formulation would be the only once-daily treatment on the market.

Company officials said they would plan to file a supplemental new drug application with the FDA in the second half of this year.