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Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis
Posted 2 Dec 2009 by Drugs.com
TAMPA, FL, September 16, 2009 – 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 (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. The FDA a ... Read more
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