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news.Sirion Therapeutics has announced positive data from two Phase III clinical trials of Durezol 0.05%, a topical steroid in the treatment of postoperative ocular inflammation.
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The two multi-center studies evaluated the safety and efficacy of Durezol 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, 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 one cell) on day eight, 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 eight. In addition, Durezol 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.
Both the BID and QID groups were superior to placebo in eliminating pain as measured using the Visual Analogue Scale. Durezol was well tolerated with few treatment related adverse events.