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FDA grants approval to twice-daily NSAID

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IRVINE, Calif. — A twice-daily ophthalmic solution of bromfenac has gained U.S. regulatory approval, according to marketer Ista Pharmaceuticals. Xibrom will be launched during the second quarter of 2005 for the treatment of ocular inflammation following cataract surgery, Ista said in a press release.

“Xibrom is the first twice-daily ophthalmic nonsteroidal anti-inflammatory drug to be approved in the United States,” said Eric Donnenfeld, MD, one of the investigators. Dr. Donnenfeld noted that other similar products are dosed four times daily.

Xibrom 0.09% is a sterile, topical NSAID for the treatment of ocular inflammation, according to Ista. Developer Senju Pharmaceuticals has been marketing the drug in Japan since 2000; Ista acquired U.S. marketing rights from Senju in 2002 when it acquired the assets of AcSentient.

According to the press release, U.S. approval was granted upon review of two pivotal phase 3 studies involving 527 patients. A statistically significant proportion of patients treated with the drug achieved treatment success, defined as complete absence of ocular inflammation after cataract surgery. Results were evident as early as day 3 following treatment initiation, according to Ista.