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Monday, July 25, 2011

Remura (Ista Pharmaceuticals, Irvine, Calif.) Remura is lowdose bromfenac, a non-steroidal anti-inflammatory drug; it’s currently available in Xibrom ophthalmic solution as a treatment for postoperative inflammation following cataract surgery. (Twice-daily Xibrom will be replaced by the newly approved oncea- day bromfenac product Bromday during the next few months.) Phase III trials of low-dose bromfenac as a treatment for dry eye are under way as of September 2010. Ista plans to conduct four randomized, doublemasked, placebo-controlled studies under a special protocol assessment agreed upon with the Food and Drug Administration; the studies will involve more than 30 sites in the United States. Two concentrations of bromfenac will be tested (both lower than Xibrom’s 0.09% concentration). To meet FDA guidance on drugs for chronic dosing, the company expects to conduct both a six-month and a 12-month safety study. According to the Ista website, the company hopes to report efficacy results by mid-2011.

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