Novartis Ophthalmics, the eye health unit of Novartis AG and QLT Inc. announced the submission of a new drug application in Japan for Visudyne (verteporfin for injection), a therapeutic treatment for AMD (age-related macular degeneration) accompanied with subfoveal CNV - the leading cause of blindness in people over age 50.
AMD is the leading cause of blindness in people over the age of 50 and is caused by a growth of abnormal blood vessels (CNV) under the central part of the retina or macula. The vessels leak fluid and blood and can lead to the development of scar tissue that destroys the central retina, resulting in a deterioration of sight over a period ranging anywhere from two months to three years.
Patients with this disease ultimately lose their central vision, which is indispensable for the activities of daily living including reading and driving. Although the wet form (the form Visudyne is used to treat) represents an estimated 15% of all AMD cases, it accounts for approximately 90% of the severe vision loss associated with the diseases. Worldwide, approximately 500,000 new cases of wet AMD occur each year and this estimate is expected to grow dramatically as the population ages.
Visudyne was evaluated in Japan as a therapeutic drug for the wet form of AMD following its designation as an orphan drug in June 1997. The results of a 6-month clinical study which were presented today at the international congress of Ophthalmology in Sydney, have shown the efficacy and excellent safety profile of Visudyne in Japanese AMD patients.
Visudyne therapy is a two-step procedure involving the intravenous administration of the drug into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. Once activated, Visudyne selectively affects abnormal blood vessels, resulting in a cessation of growth of blood vessels in the eye and a stabilization of the corresponding vision loss. Visudyne therapy does not appear to damage normal retinal vessels. In Japan, Carl Zeiss Co. Ltd., and Lumenis Japan, Ltd. submitted pre- marketing approval applications for laser devices, which would be used in Visudyne therapy.
Visudyne is commercially available in 62 countries for the treatment of certain types of predominantly classic subfoveal CNV caused by AMD. It is also approved in over 40 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness).
In the U.S., Visudyne has received an additional approval for CNV due to presumed ocular histoplasmosis. Over 150,000 patients have undergone Visudyne therapy worldwide since its US launch in April 2000. If approved, Visudyne could be beneficial to patients in Japan suffering from this devastating eye disease that to date has no other pharmaceutical effective therapy.