Healthcare Industry News: orphan drug designation
News Release - January 26, 2009
Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular HerpesTAMPA, Fla., Jan. 26 -- (Healthcare Sales & Marketing Network) -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. 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 U.S. 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%, with acyclovir ointment, 3%, both of which are used as first-line therapies outside the U.S. 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 U.S. clinicians who treat herpetic keratitis," noted Herb Kaufman, M.D., Sirion Ophthalmologist Emeritus and renowned herpetic keratitis researcher and clinician.
About Herpetic Keratitis
Herpes simplex virus (HSV) infections are very common, with nearly 60% of the U.S. population showing evidence of infection by age five. Approximately 1% of infected patients develop ocular outbreaks, with 20,000 primary cases of ocular herpes diagnosed in the U.S. each year.
After the primary infection, ocular HSV typically becomes latent until triggers such as stress, UV radiation, and hormonal changes reactivate the virus and cause recurrent outbreaks. Those recurrences account for an additional 28,000 cases per year in the U.S. The risk of blindness increases with the number and severity of recurrences, making prompt treatment imperative to limit scarring and other more serious complications caused by herpetic epithelial ulcers.
About Ganciclovir Ophthalmic Gel, 0.15%
Sirion Therapeutics has an exclusive licensing agreement with Laboratoires Thea of France for the U.S. rights to develop and market ganciclovir ophthalmic gel, 0.15%. Available in Europe under the brand name VirganŽ, this topical ophthalmic antiviral gel has successfully treated herpetic viral infections for more than 10 years.
In 2007, Sirion received orphan drug designation from the FDA for ganciclovir ophthalmic gel. This designation is a special status for diseases or conditions that affect fewer than 200,000 patients in the United States.
About Sirion Therapeutics, Inc.
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. Sirion's diverse product portfolio includes products that address ocular diseases and conditions including uveitis, herpetic keratitis, dry eye, glaucoma and geographic atrophy associated with dry AMD. For more information, please visit www.siriontherapeutics.com.
About Laboratoires Thea
Laboratoires Thea (www.laboratoires-thea.com) was founded in 1994 and is managed by Henri and Jean-Frederic Chibret. Laboratoires Thea is the leading independent ophthalmic group in Europe and is committed to the development and marketing of innovative ophthalmic drugs, medical devices and nutraceuticals.
Source: Sirion Therapeutics
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