Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammatio...(es particularly the ability to eliminate...)

Sirion Therapeutics plans to make Durezol commercially available in late 2008.

Phase 3 Program Results

The two U.S. Phase 3 multi-center studies evaluated the safety and efficacy of Durezol compared to placebo dosed twice a day (BID) and four times a day (QID) beginning 24 hours after intraocular surgery. Treatment occurred over 4 weeks and included tapering. The studies included 438 subjects who presented with significant inflammation as evidenced by an anterior chamber cell grade 2 or higher (greater than 10 cells) the day after surgery.

Both regimens (BID and QID) had similar overall efficacy in the reduction of anterior chamber cells two weeks following surgery (86% in BID and 87% in QID). The QID regimen had a small numerical advantage in the number of patients who were completely free of inflammation and pain at the one week time point. Because of this numerical advantage, and the desire to treat inflammation aggressively, the QID dosing regimen was chosen for recommendation to doctors.

Durezol was well tolerated with few treatment related adverse events. One of the most common side effects seen with steroids in ophthalmic use is a rise in IOP. Three percent of subjects in each of the BID and QID groups, and one percent of subjects in the placebo group met the criterion for a clinically significant rise in IOP, defined as an observed value of greater than or equal to 21 mm Hg and a change from baseline of 10 mm Hg.

About Postoperative Inflammation

More than five million ophthalmic surgeries are performed each year in the United States. Postoperative inflammation and pain are common occurrences following these procedures and if left untreated, can interfere with a patient's visual rehabilitation or lead to further complications. Corticosteroids and non-steroidal anti-inflammatory dru
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