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

continued throughout the study period.

Two patients in each treatment arm experienced criterion increases 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 10mmHg at the same visit). Another important safety finding was the number of patients withdrawn from the study due to lack of efficacy. In the Pred Forte group, 12.5% of patients were withdrawn from the study, while no Durezol patients were withdrawn from the study for these reasons. This difference was significant, P=0.01.

The results from this study will be combined with data from previous trials conducted in Japan to support a supplemental New Drug Application for anterior uveitis. "The results of these trials are truly exciting," noted Barry Butler, CEO and President of Sirion Therapeutics. "Although this study was not designed to detect the statistical superiority of one drug over the other, the consistent numerical advantage of Durezol across all endpoints is impressive. This is especially so, when you consider that Pred Forte has 20 times the concentration of Durezol and was dosed twice as often. This clearly demonstrates the potency of Durezol."

About Uveitis

Uveitis is inflammation of the middle three layers of the eye: iris, choroid, and ciliary body. In the US it is responsible for an estimated 30,000 new cases of legal blindness each year and up to 15% of all cases of blindness. It affects 0.2% of the population in industrial nations, with as much as 10 times that prevalence in the undeveloped world. The most common form of the condition is anterior uveitis, associated primarily with inflammation of the iris. If left untreated, uveitis can cause permanent damage and vision loss due to the development of glaucoma, cataract, or retinal edema. In addition to causing blindness, the severe pain and photophobia that accompany anterior uveitis can be debilitating.

About Durezol

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SOURCE Sirion Therapeutics, Inc.
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