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Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes
Date:1/26/2009

valuable treatment option for U.S. clinicians who treat herpetic keratitis," noted Herb Kaufman, M.D., Sirion Ophthalmologist Emeritus and renowned herpetic keratitis researcher and clinician.

About Herpetic Keratitis

Herpes simplex virus (HSV) infections are very common, with nearly 60% of the U.S. 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 U.S. each year.

After the primary infection, ocular HSV typically becomes latent until triggers such as stress, UV radiation, and hormonal changes reactivate the virus and cause recurrent outbreaks. Those recurrences account for an additional 28,000 cases per year in the U.S. The risk of blindness increases with the number and severity of recurrences, making prompt treatment imperative to limit scarring and other more serious complications caused by herpetic epithelial ulcers.

About Ganciclovir Ophthalmic Gel, 0.15%

Sirion Therapeutics has an exclusive licensing agreement with Laboratoires Thea of France for the U.S. rights to develop and market ganciclovir ophthalmic gel, 0.15%. 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 diseases or conditions that affect fewer than 200,000 patients in the United States.

About Sirion Therapeutics, Inc.

Sirion Therapeutics 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 product portfolio includes products that address
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SOURCE Sirion Therapeutics, Inc.
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