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.
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 US 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, the company said.
Barry Butler, CEO of Sirion Therapeutics, said: If approved by the FDA, ganciclovir ophthalmic gel would become the first topical ophthalmic antiviral treatment launched in the US in almost three decades. This product would provide a significant new option for physicians in the treatment of patients with herpetic keratitis.