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Ista submits new drug application for Xibrom
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IRVINE, Calif. — Ista Pharmaceuticals Inc. filed a new drug application with the Food and Drug Administration for its topical nonsteroidal anti-inflammatory solution.
According to the company, Xibrom (bromfenac sodium ophthalmic solution 0.1%), is initially being developed as a twice-daily treatment for ocular inflammation following cataract surgery. It was initially launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. Ista acquired U.S. marketing rights to the drug in May 2002.
Ista reported in March 2004 that two double-masked, placebo-controlled phase 3 studies, conducted under a single protocol, showed significantly more patients treated with Xibrom had complete absence of ocular inflammation compared to patients receiving placebo.
Analyzed separately, both studies also showed that Xibrom was well tolerated and has a low incidence of adverse events, the company said.
Ista is waiting to hear from the FDA whether it accepted the filing of the application.