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ISTA Pharmaceuticals Announces Positive Preliminary Results from,Ecabet Sodium Phase IIb Study

a predetermined endpoint in this study, 14 percent of patients in the treatment group reported increases in the quantity of tears produced, as compared to only 1.8 percent in the placebo group. We are continuing our analyses of both of our Phase II clinical studies to identify the signs and symptoms to evaluate in Phase III testing. Upon completion of the analyses, we will request a meeting with the Food and Drug Administration to discuss its recommended clinical path in order to bring this novel treatment to patients suffering from dry eye syndrome. At this time, we anticipate beginning Phase III studies in 2008."

A total of 112 patients were assigned randomly to receive either ecabet sodium or placebo four times a day for 90 days. There were four primary efficacy endpoints: two objective signs (blink rate and corneal staining) and two subjective symptoms (the patient's most bothersome symptom and the patient's response to the Ocular Surface Disease Index (OSDI)). Patients were evaluated in a controlled adverse environment ("dry eye chamber") twice during the study, once on Day 1 and once on Day 91. The objective signs were measured pre- and post-exposure to the dry eye chamber on Day 91. The subjective symptoms were measured following exposure to the dry eye chamber on both Day 1 and Day 91. To date, the FDA has considered improvement, as measured in Phase III studies, in one sign and one symptom to be acceptable for approval of a prescription dry eye product.

ISTA will host a conference call with a simultaneous webcast tomorrow, Friday, June 1, 2007, at 11:00 AM Eastern Time to discuss today's announcement regarding the ecabet sodium Phase IIb study preliminary results and other recent product and commercial developments. To access the live conference call, U.S. and Canadian participants may dial 866-356-4281; international participants may dial 617-597-5395. The access code for the live call is 93323302. To access the 24-hour audio replay, U.S. an
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