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Sirion Therapeutics Announces Positive Results From Interim Analysis of Phase II Trial and Receives FDA Fast Track Designation for Fenretinide
Date:4/15/2009

announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for fenretinide for the treatment of geographic atrophy associated with age-related macular degeneration.

"Our receipt of Fast Track designation has the potential to accelerate the development of fenretinide for the treatment of geographic atrophy, which is a condition without a currently approved treatment," said Barry Butler, CEO of Sirion Therapeutics. "The Fast Track designation combined with our positive interim analysis results gives Sirion a great deal of optimism that we will be able to bring a much needed treatment option to patients with geographic atrophy."

About Fast Track Designation

The Fast Track programs of the FDA are designed to facilitate the development of drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition. Fast Track designation provides the option to submit a New Drug Application on a rolling basis, and thus enable the FDA to begin reviewing sections of the application before receiving the complete application. New Drug Applications for products with a Fast Track designation also generally receive a priority review designation, meaning the application will be reviewed in six months rather than the 10-month standard review time.

About Fenretinide

Fenretinide is an oral vitamin A binding protein antagonist being studied in patients with geographic atrophy (GA), the most advanced form of dry age-related macular degeneration (AMD). Fenretinide is believed to halt the accumulation of retinol (vitamin A) toxins through affinity for retinol-binding protein. It is also believed to slow the formation and accumulation of toxic byproducts thought to be responsible for vision loss in conditions such as GA.

About Geographic Atrophy

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SOURCE Sirion Therapeutics, Inc.
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