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Video: Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain
Date:10/6/2008

dies that evaluated Durezol for the management of postoperative inflammation in which treatment was initiated one day prior to surgery. The multicenter, randomized, double-masked, placebo-controlled, parallel-group trials were conducted in 245 patients undergoing unilateral ocular surgery. In the first study of 124 patients, Durezol or placebo was dosed 4 times daily (QID), while in the second study, 121 patients received Durezol or placebo twice daily (BID).

"The Phase 3b studies represent an approach to therapy that is most similar to the current standard of care, meaning most physicians treat inflammation prophylactically rather than waiting for it to occur," explained Steven Silverstein, M.D. of Silverstein Eye Centers. Dr. Silverstein was a principal investigator in the QID study and also serves as a clinical assistant professor of ophthalmology at the University of Missouri-Kansas City School of Medicine and the University of Health Sciences. "Overall, the results from these studies show that by any definition utilized, Durezol administered both BID and QID was more effective than placebo in treating postoperative ocular inflammation and relieving ocular pain/discomfort as early as Day 3/4."

A significantly greater percentage of patients receiving Durezol QID or BID achieved a clinical response (defined as less than or equal to 5 anterior chamber cells and no flare) by Day 14: 81.3% of the Durezol treated patients in the QID group had a clinical response versus 25.0% of the placebo QID group (P < 0.0001); 74.7% of the Durezol BID patients had a clinical response versus 42.5% of patients in the placebo BID group (P < 0.001). Both Durezol groups maintained superiority over the placebo groups through Day 28, demonstrating that efficacy was definitive and did not decrease or reverse over time.

Ocular pain/discomfort was measured using the Visual Analogue Scale (VAS) score of 0-100 with 0 equal to no pain and 100 equal to maximal pain. The perc
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SOURCE Sirion Therapeutics, Inc.
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