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ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease
Date:6/8/2009

IRVINE, Calif., June 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced positive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease (keratoconjuctivitis sicca) using a new, proprietary, low-dose formulation of bromfenac, the active ingredient in Xibrom(R) (bromfenac ophthalmic solution) 0.09%. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (Lissamine Green test) as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining (Fluorescein test) as compared to baseline. Patients also achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) and improvement in patients' most bothersome ocular symptoms.

"The strong clinical results from this proof-of-concept study further support our belief that a modified, low-dose formulation of bromfenac has the potential ability to effectively and conveniently treat signs and symptoms of dry eye disease and provide fast and sustainable relief for patients. Bromfenac's strong safety profile should support long-term treatment, which would be necessitated due to the chronic inflammatory nature of dry eye disease," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals.

"ISTA is strongly committed to focusing on dry eye disease. The results of this study may help identify patients that would be most suitable for a larger, placebo-controlled study. These data come on the heels of our recently announced positive ecabet sodium Phase 2b study results in ISTA's dry eye franchise. We will analyze the data from both programs to determine which product candidate or candidates to move into further advanced stud
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SOURCE ISTA Pharmaceuticals, Inc.
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