Herpetic keratitis treatment NDA accepted by FDA

January 28, 2009

A new drug application (NDA) has been accepted for review by the FDA for the approval of a treatment (ganciclovir, Sirion Therapeutics) for herpetic keratitis.

Tampa, FL-A new drug application (NDA) has been accepted for review by the FDA for the approval of a treatment (ganciclovir, Sirion Therapeutics) for herpetic keratitis.

"Herpes simplex keratitis remains one of the leading causes of corneal blindness and corneal transplants in the United States. 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,” said Barry Butler, chief executive officer of Sirion Therapeutics. “This product would provide a significant new option for physicians in the treatment of patients with herpetic keratitis."

Four randomized, multicenter trials assessed the efficacy and safety comparing the treatment with another treatment (acyclovir, GlaxoSmithKline), both of which are used outside the United States to treat herpetic keratitis.

Study results showed that the new drug is just as effective as the treatment it was compared with, and that the tolerability of the new drug was superior, particularly with regard to blurring and stinging or burning sensations after instillation. Additionally, since the new drug is formulated as an aqueous gel, it allows for prolonged contact time with the corneal surface, according to investigators.

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