Sirion Therapeutics, Inc.’s anti-viral therapy –ganciclovir – has been awarded Orphan Drug Designation by the USFDA for the treatment of acute herpetic keratitis.
Ganciclovir is currently marketed Laboratoires Thea in Europe under the brand name of Virgan®.
According to Christine Miller, Sirion's Vice President of Regulatory Affairs:
"We are pleased to receive orphan drug designation from the FDA for Ganciclovir. Topical ganciclovir has been available in Europe for the treatment of ocular viral infections for over 10 years.
This product has the potential to advance medical treatment of herpes simplex keratitis in the U.S. Herpes simplex keratitis is a leading cause of corneal blindness in the United States."
Sirion licensed the U.S. rights to Virgan® from Laboratoires Thea in January 2007.
Read the full report (a pdf file).
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