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ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium
Date:1/22/2009

of dry eye disease in the first half of 2009. Once this lower strength Xibrom trial is completed, we will make a decision on which product or products in our dry eye franchise to move into Phase III trials, which could start as early as 2010."

ISTA's previous two Phase II trials of ecabet, which were conducted in a controlled environment chamber, demonstrated positive trends in patient's symptoms (OSDI and patient's worst symptom, both trials) and in the signs of corneal staining (one trial) and blink rate (both trials). The Company believes the lack of response to ecabet in symptoms in the most recent trial is not of concern, in part because the OSDI responses to ecabet sodium were strong and predictable in the previous Phase II trials. ISTA believes that given the ability to demonstrate a positive effect on signs in the environment and on symptoms in the controlled environment chamber, there is now a clear path forward to Phase III studies and New Drug Application filing for this product.

Background on ISTA's Recent Phase IIb Study Results

ISTA's Phase IIb trial randomized 144 patients to receive either ecabet sodium or placebo four times per day for 43 days. The object of the study was to investigate ecabet sodium's effects on the objective signs of tear production (Anesthetized and Unanesthetized Schirmer Tests) and tear film quality (TFBUT) and subjective symptoms (OSDI, patient's worst symptom) in patients with dry eye disease when administered under normal environmental conditions.

In the analysis of responders to both ecabet sodium and placebo, results of the Anesthetized Schirmer Test in the Phase IIb study revealed a strong trend for ecabet sodium, which approached statistical significance versus placebo. This result is important because it indicates an effect on basal tear secretion, which is one of the main factors in the etiology of dry eye disease. In addition, the percentage of
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SOURCE ISTA Pharmaceuticals, Inc.
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