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Sirion Therapeutics Highlights Pivotal Trial Results of Durezol(TM) at the American Society of Cataract and Refractive Surgery Annual Symposium
Date:4/8/2008

TAMPA, Fla., April 8, 2008 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today the presentation of data from two Phase 3 clinical trials of Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid in the treatment of postoperative ocular inflammation. The results were given in a presentation by Michael Korenfeld, MD during the American Society of Cataract and Refractive Surgery Annual Symposium in Chicago, Illinois.

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The two multi-center studies evaluated the safety and efficacy of Durezol(TM) 0.05% compared to placebo dosed twice a day (BID) and four times a day (QID) beginning 24 hours after ocular surgery. The studies included 438 subjects who presented with an anterior chamber cell grade 2 (greater than or equal to 10 cells) or higher the day after surgery. The clinically and statistically significant findings demonstrated that Durezol(TM), at both the BID and QID dosing regimens, was superior to placebo in achieving the primary endpoint of proportion of subjects with an anterior chamber cell grade of 0 (less than or equal to 1 cell) on Day 8, with 30% of subjects in the BID group reaching Grade 0 versus 9% in the placebo group. Of the subjects in the QID group, 35% reached Grade 0 on Day 8. In addition, Durezol(TM) maintained superiority over placebo through the treatment period (Day 15), with 56% in the BID group and 63% in the QID group reaching Grade 0 versus 16% in the placebo group.

Further data from the presentation demonstrated that both the BID and QID dosing regimens were superior to placebo with regard to change from baseline in anterior chamber cell count at Day 8. The mean reduction in cell count for subjects in both the BID and QID groups was 19 cells and the mean reduction in the placebo gr
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SOURCE Sirion Therapeutics, Inc.
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