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Title: FDA Approves Topical Steroid for Treatment of Postoperative Ocular Inflammation, Pain
URL: http://www.pslgroup.com/dg/224306.htm
Doctor's Guide
June 24, 2008

NEW YORK -- June 24, 2008 -- The US Food and Drug Administration (FDA) has approved difluprednate ophthalmic emulsion (Durezol) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a 6 month priority review.

Two phase 3 trials evaluated the safety and efficacy of difluprednate ophthalmic emulsion compared to placebo after intraocular surgery. The studies included 438 patients who presented with significant inflammation as evidenced by an anterior chamber cell grade 2 or higher the day after surgery. Patients were given a dosage of either BID or QID beginning 24 hours after intraocular surgery.

Both regimens (BID and QID) had similar overall efficacy in the reduction of anterior chamber cells 2 weeks following surgery (86% in BID, 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 1-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.

Difluprednate ophthalmic emulsion 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 mean intraocular pressure (IOP). Three percent of patients in each of the BID and QID groups, and 1% of patients in the placebo group met the criterion for a clinically significant rise in IOP.


SOURCE: Sirion Therapeutics

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