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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

TAMPA, Fla., Jan. 26 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus. The FDA has issued an action date in late fall of 2009, under the Prescription Drug User Fee Act.

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"Herpes simplex keratitis remains one of the leading causes of corneal blindness and corneal transplants in the United States," explained Barry Butler, CEO of Sirion Therapeutics. "If approved by the FDA, ganciclovir ophthalmic gel would become the first topical ophthalmic antiviral treatment launched in the U.S. in almost three decades. This product would provide a significant new option for physicians in the treatment of patients with herpetic keratitis."

To assess the efficacy and safety of ganciclovir, four randomized, multicenter trials compared ganciclovir gel, 0.15%, with acyclovir ointment, 3%, both of which are used as first-line therapies outside the U.S. to treat herpetic keratitis. The studies found that ganciclovir is as effective as acyclovir and that the tolerability of ganciclovir was superior to acyclovir, particularly with regard to blurring and stinging or burning sensations after instillation. Additionally, since ganciclovir is formulated as an aqueous gel, it allows for prolonged contact time with the corneal surface.

"Based upon its proven safety and efficacy, the introduction of a new topical antiviral agent with improved tolerability, such as ganciclovir ophthalmic gel, would clearly be a
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SOURCE Sirion Therapeutics, Inc.
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