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Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
Date:10/14/2008

TAMPA, Fla., Oct. 14 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today preliminary results from a pivotal anterior uveitis trial that compared Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% dosed four times daily (QID) to Pred Forte(R) (prednisolone acetate ophthalmic suspension) 1%, dosed eight times daily. Durezol is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery; it was approved by the US Food and Drug Administration in June 2008. Pred Forte(R) is the registered trademark of Allergan, Inc.

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Ninety patients with endogenous anterior uveitis were studied in a multicenter, randomized, double-masked trial that compared the efficacy and safety of Durezol QID with Pred Forte eight times a day. Treatment for both study groups was administered for 14 days, with 2 weeks of tapering at half the dose and 2 weeks of follow-up (for a total 42 days) after initiation of therapy.

The primary endpoint was the difference from baseline in anterior chamber (AC) cell grades between the Durezol and Pred Forte groups. At Day 14, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, confirming the noninferiority of Durezol dosed QID to Pred Forte dosed eight times a day.

"This study shows that Durezol is a potent steroid that can be used effectively four times a day to reduce inflammation in patients with moderate to severe uveitis," explained C. Stephen Foster, MD, an investigator in the trial and the founder and president of the Massachusetts Eye Research and Surgery Institution. "This is especially important since the US standard of care currently necessitates dosing steroids every hour -- and as frequently
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SOURCE Sirion Therapeutics, Inc.
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