Once-daily Xibrom effective in Ph III study

California, USA-based drugmaker ISTA Pharmaceuticals says that the preliminary analysis of results from a series of Phase III trials of Xibrom (bromfenac sodium opthalmic solution) once-daily formulation, indicate that the agent was highly effective in the treatment of ocular pain following cataract surgery. The firm currently sells a twice-daily version of the product in the USA, under a license acquired from its originator, Japan's Senju Pharmaceuticals, in June 2005 (Marketletters passim).

The multicenter study program evaluated the once-daily formulation of the drug, which contains a higher concentration of the active ingredient bromfenac, in comparison placebo in over 500 patients who had undergone cataract removal operations.

The initial findings indicate that the product effectively treats eye pain and has a safety profile similar to the currently marketed compound. The company said it plans to file the drug with US regulators later this year.