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

entage of patients who were free of ocular pain/discomfort, reflected by a VAS score of 0, was superior and statistically significant for the Durezol groups versus the placebo groups in both the QID and BID studies as early as Day 3/4 and throughout the study period.

Six percent of the Durezol QID patients and 3.7% of the Durezol BID patients experienced a criterion increase in intraocular pressure, defined as a pressure of greater than or equal to 21 mmHg and a change from baseline greater than or equal to 10 mmHg at the same visit, compared with 0% in both of the placebo groups.

"Durezol has shown efficacy across multiple endpoints, including pain reduction. I believe it provides a potent new treatment option with a favorable safety profile," commented Dr. Silverstein. "It is a welcome improvement to the armamentarium of ocular pharmaceuticals, particularly since ocular inflammation is common to the majority of conditions that ophthalmologists treat."

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 drugs are commonly used by healthcare professionals following ophthalmic surgery.

About Durezol

Durezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic corticosteroid for the treatment of inflammation and pain associated with ocular surgery. Difluprednate, the active ingredient in Durezol, is a difluorinated derivative of prednisolone and has potent anti-inflammatory activity. Prior to U.S. approval, the efficacy and safety of difluprednate in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan. In two U.S. Phase 3 trials evaluating Durez
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SOURCE Sirion Therapeutics, Inc.
Copyright©2008 PR Newswire.
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