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Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammation and Pain
Date:6/24/2008

Durezol is First Ophthalmic Steroid Indicated for Inflammation and Pain

TAMPA, Fla., June 24 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review.

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"Durezol, our first product to be approved by the FDA, is a potent topical steroid that works rapidly and effectively to resolve postoperative inflammation and pain," said Barry Butler, President and CEO of Sirion Therapeutics, Inc. "We look forward to launching the first innovation in the strong steroid class in more than 35 years, and the first steroid to have an indication for the treatment of postoperative pain. We believe that having access to a steroid that treats both inflammation and pain gives physicians a more complete treatment approach."

In two Phase 3 trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol rapidly reduced inflammation and pain. Mean intraocular pressure (IOP) for all study groups remained within the normal range throughout the study.

"Rapid resolution of inflammation and pain is very important following ocular surgery," said Dr. Michael Korenfeld, M.D., Assistant Clinical Professor of Ophthalmology and Visual Sciences, Washington University, St. Louis, MO, and principal investigator for the Phase 3 trials. "It is important to point out that in these Phase 3 studies, patients were dosed for the first time after the ocular trauma from surgery had occurred. The results from these studi
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SOURCE Sirion Therapeutics, Inc.
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