Herpetic Keratitis drug Ganciclovir from Sirion is waiting for FDA approval

The U.S. Food and Drug Administration has already accepted for review a new Herpetic Keratitis drug Ganciclovirfor an eye treatment from Sirion Therapeutics Inc. The FDA has issued an action date in late fall of this year.

Sirion is a privately held ophthalmic-focused biopharmaceutical company headquartered in Tampa.

Sirion's Ganciclovir ophthalmic gel as a treatment for herpetic keratitis would be the first topical antiviral treatment for eye launched in the United States in almost three decades, if FDA approved.

In clinical trials, Sirion’s gel was found to be as effective as an existing therapy and it caused less blurring and stinging.

Herpetic Keratitis disease is caused by the herpes simplex virus. Herpes simplex keratitis is the leading cause of corneal blindness in industrialized nations. It is an increasingly significant problem in developing nations as well. Of the estimated 50,000 cases reported annually in the U.S., about 50% are estimated to be recurrent cases.

The herpes simplex virus is very common. Most people have a herpetic infection at some time of their lives. However, only in a few unlucky people does the virus affect the cornea.

No one knows why some people develop corneal infections not others. It has nothing to do with sex, that is a totally different type of herpes virus.

Herpetic keratitis is listed as a "rare disease" by the Office of Rare Diseases (ORD) of the National Institutes of Health (NIH). This means that Herpetic keratitis, or a subtype of Herpetic keratitis, affects less than 200,000 people in the US population.

Source: Business Journal


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