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www.fdanews.com/articles/90242-ista-announces-positive-data-on-once-daily-xibrom

ISTA ANNOUNCES POSITIVE DATA ON ONCE-DAILY XIBROM

February 13, 2007

Ista Pharmaceuticals has announced highly statistically significant results from its initial analysis of the Phase III clinical trials of its Xibrom once-daily formulation.

The multicenter studies evaluated the Xibrom (bromfenac sodium ophthalmic solution) once-daily formulation versus placebo in more than 500 patients who underwent cataract surgery. The preliminary results demonstrate that Xibrom was highly statistically significant in treating postoperative ocular pain and inflammation associated with cataract surgery. Additionally the safety profile is consistent with the currently marketed Xibrom formulation.

The Xibrom once-daily formulation contains a higher concentration of the active ingredient, bromfenac, than the original twice-daily product. If approved, this Xibrom formulation will provide patients with a significant improvement in treating ocular pain and inflammation associated with cataract surgery, and it will be the only available once-a-day treatment, according to Ista.

The company plans to file a supplemental new drug application sometime during the second half of 2007.

Xibrom is a topical non-steroidal anti-inflammatory drug (NSAID) for the treatment of ocular inflammation and pain. Launched in the U.S. in 2005, the drug was the first and only FDA-approved twice-daily NSAID for treating inflammation and pain following cataract surgery.