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Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA
Date:3/16/2009

Application Includes Data from a Comparative Trial in Anterior Uveitis

TAMPA, Fla., March 16 /PRNewswire/ -- Sirion Therapeutics, Inc. announced today that its supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) seeking market approval of Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% to treat endogenous anterior uveitis has been accepted for review. Durezol, developed and marketed by Sirion Therapeutics, was approved by the FDA in June 2008 for the treatment of post-operative inflammation and pain associated with ocular surgery.

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"Uveitis is a debilitating and painful condition, and is one of the leading causes of blindness in the US," said Barry Butler, CEO of Sirion Therapeutics. "We are encouraged that the FDA is reviewing the application for our drug, which has the potential to treat this sight threatening condition."

The supplemental application includes data from several clinical studies, including one recently completed trial in the US of 90 patients with endogenous anterior uveitis that compared Durezol dosed QID to Pred Forte(R) (prednisolone acetate ophthalmic suspension) 1%, Allergan, dosed 8 times a day. In this study, Durezol was found to be non-inferior to Pred Forte in reducing the mean anterior chamber cell grade at Day 14 (mean cell grade reduction of 2.1 compared to 1.9). In addition, Durezol was numerically superior in almost every efficacy measure, including the reduction of anterior chamber flare and the reduction of signs and symptoms of inflammation. Notably, 12.5% of patients in the Pred Forte group were withdrawn from the trial due to lack of efficacy, while no patients were withdrawn from the Durezol group for this reason.

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SOURCE Sirion Therapeutics, Inc.
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