The FDA has accepted for review a new drug application filed by Sirion Therapeutics Inc. for ganciclovir ophthalmic gel 0.15%.
-The FDA has accepted for review a new drug application filed by Sirion Therapeutics Inc. for ganciclovir ophthalmic gel 0.15%. The company is seeking approval for the drug as a treatment for herpetic keratitis. The federal agency expects to complete its review by late fall, according to Sirion Therapeutics.
“If approved by the FDA, ganciclovir ophthalmic gel would become the first topical ophthalmic antiviral treatment launched in the United States 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.”
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 United States to treat herpetic keratitis. The studies found that ganciclovir was 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, according to Sirion Therapeutics. Additionally, the company stated, because ganciclovir is formulated as an aqueous gel, it allows for prolonged contact time with the corneal surface.