Sirion Therapeutics, Inc, a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15 per cent, has been accepted for review by the US Food and Drug Administration (FDA). 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.
"Herpes simplex keratitis remains one of the leading causes of corneal blindness and corneal transplants in the United States," explained Barry Butler, CEO of Sirion Therapeutics. "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."
To assess the efficacy and safety of ganciclovir, four randomized, multicenter trials compared ganciclovir gel, 0.15 per cent, with acyclovir ointment, 3 per cent, 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.
"Based upon its proven safety and efficacy, the introduction of a new topical antiviral agent with improved tolerability, such as ganciclovir ophthalmic gel, would clearly be a valuable treatment option for US clinicians who treat herpetic keratitis," noted Herb Kaufman, Sirion Ophthalmologist Emeritus and renowned herpetic keratitis researcher and clinician.
Sirion Therapeutics has an exclusive licensing agreement with Laboratoires Théa of France for the US rights to develop and market ganciclovir ophthalmic gel, 0.15 per cent. Available in Europe under the brand name Virgan, this topical ophthalmic antiviral gel has successfully treated herpetic viral infections for more than 10 years.
Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development, and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight.
Laboratoires Théa was founded in 1994 and is managed by Henri and Jean-Frederic Chibret. Laboratoires Théa is the leading independent ophthalmic group in Europe and is committed to the development and marketing of innovative ophthalmic drugs, medical devices and nutraceuticals.