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Sirion Therapeutics Announces FDA Approval of Zirgan(TM) (Ganciclovir Ophthalmic Gel) 0.15% for Herpetic Keratitis
Date:9/21/2009

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In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 patients, Zirgan was noninferior to acyclovir in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% (41/57) for Zirgan versus 69% (34/49) for acyclovir.

"The approval of Zirgan represents a true advance in topical antiviral therapies in the US," commented Barry Butler, CEO of Sirion. "Up to this point, no therapy targeting only viral-infected cells was available for topical ocular use. Zirgan provides doctors with a much needed modern treatment for herpetic keratitis."

The recommended dosing regimen for Zirgan is 1 drop in the affected eye 5 times per day until the ulcer heals, and then 1 drop 3 times per day for 7 days. Trifluridine ophthalmic solution, which is commonly used for topical treatment of herpetic keratitis, is dosed at 1 drop every 2 hours while awake for a maximum of 9 drops daily until the ulcer heals. Zirgan will be supplied in a 5 gram tube and will be available by prescription through retail pharmacies.

"We anticipate Zirgan will be commercially available to US physicians in early 2010," noted Susan Benton, Senior Vice-President of Sales and Marketing for Sirion. "We're pleased to introduce this important treatment option for herpetic keratitis to the US," she continued, "especially since it has been the standard of care in the Europe for over 10 years. We believe it will provide patients and physicians with an effective, safe, and convenient treatment for herpetic keratitis."

About Herpetic Keratitis

Herpes simplex virus infections are very common, with nearly 60% of the US population showing evidence of infection by age five. Approximately 1% of infected patients develop ocular outbreaks, with 20,000 primary cases of ocular herpes diagnosed in the US each year. After the primary infection, ocular HSV typically b
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SOURCE Sirion Therapeutics, Inc.
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