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Sirion Therapeutics Announces FDA Approval of Zirgan(TM) 0.15% for Herpetic Keratitis Zirgan


9/16/2009 8:46:48 AM

TAMPA, Fla., Sept. 16 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for this indication in April 2007.

Herpetic keratitis, an ocular disease caused by the herpes simplex virus (HSV), is a significant cause of corneal blindness and a leading indication for corneal transplantation in the US, with approximately 50,000 new and recurrent cases each year. After the initial outbreak, HSV becomes a latent infection in the trigeminal ganglion or cornea, with repeated recurrences that frequently lead to corneal scarring and ocular inflammation, increasing the risk of blindness.

In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, Zirgan was non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution (defined as percentage of healed ulcers) at Day 7 was achieved in 77% (55/71) for Zirgan versus 72% (48/67) 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."

"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 Zirgan(TM) (ganciclovir ophthalmic gel) 0.15%

Zirgan is the trademark of Laboratoires Thea of France and Sirion Therapeutics, Inc., has the exclusive US rights to develop and market Zirgan. Available in Europe under the brand name Virgan(R), this topical ophthalmic antiviral gel has successfully treated herpetic viral infections for more than 10 years. In 2007 Sirion received orphan drug designation from the FDA for ganciclovir ophthalmic gel. This designation is a special status for rare diseases or conditions that affect fewer than 200,000 patients in the US.

About Sirion Therapeutics, Inc.

Sirion Therapeutics, Inc. is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion's diverse portfolio includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, glaucoma, and geographic atrophy associated with dry AMD. For more information, please visit www.siriontherapeutics.com.

SOURCE Sirion Therapeutics, Inc.



CONTACT: Erin Parsons of Sirion Therapeutics, Inc., +1-813-919-9410,
eparsons@siriontherapeutics.com

Web site: http://www.siriontherapeutics.com/



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