a little more colour on the Nov 17th FDA subcommittee meeting...
Monday October 4, 2:08 pm Eastern Time
Company Press Release
SOURCE: CIBA Vision Corporation
CIBA Vision and QLT PhotoTherapeutics Announce
FDA Advisory Committee Review for Visudyne
Therapy
ATLANTA and VANCOUVER, British Columbia, Oct. 4 /PRNewswire/ -- CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI; Toronto) announced today that a key advisory subcommittee of the U.S. Food and Drug Administration (FDA) will convene on November 17, 1999, to review the companies' recent New Drug Application (NDA), filed by the companies on August 16, for marketing clearance for Visudyne(TM) therapy for the treatment of wet age-related macular degeneration (AMD).
The FDA's Ophthalmic Drugs Subcommittee of the Dermatologic and Ophthalmic Drugs Advisory Committee will review the data contained in the NDA and make its recommendations, which, as always, are not binding on the FDA. Specifically, the companies' submission seeks clearance to market Visudyne therapy for the treatment of wet AMD in patients with predominantly classic subfoveal choroidal neovascularization, the most aggressive cause of vision loss associated with the disease, for which Visudyne therapy showed a dramatic benefit.
As previously announced, the FDA has assigned priority review status to the NDA for Visudyne therapy, indicating that the regulatory agency will act on the application within six months of the August filing date. Pending regulatory approval, CIBA Vision and QLT expect Visudyne therapy will be available in the U.S. in early 2000.
''We are pleased that the FDA has been able to schedule a meeting of the subcommittee so promptly after the filing of our NDA and we look forward to working closely with the FDA and the subcommittee as they review our submission,'' said Dr. Julia Levy, President and Chief Executive Officer of QLT.
''Both the priority designation and this prompt hearing are important steps toward our goal of making Visudyne therapy generally available as soon as possible for the many thousands of patients who lose their vision every year to this devastating disease,'' said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit.
Wet AMD, the leading cause of blindness in people over the age of 50 in the western world, is characterized by the formation of abnormal leaky blood vessels (choroidal neovascularization) that grow across the central part of the retina, called the macula. The wet form represents an estimated 15% of all AMD cases but accounts for approximately 90% of the severe vision loss associated with the disease. Currently available treatments have limited effectiveness and are only useful in approximately 10% to 20% of the 500,000 new cases of wet AMD that develop worldwide every year.
Initial one-year results were first released by the companies in January 1999. A comprehensive analysis of the data is expected to be published shortly in an upcoming issue of Archives of Ophthalmology, a leading ophthalmic peer-reviewed journal.
About Visudyne Therapy
Visudyne therapy can be performed in a doctor's office and is relatively painless to the patient. Visudyne therapy is a two-stage process.
First, Visudyne is injected intravenously into the patient's arm. It accumulates in the abnormal vessels in the eye. The drug is then activated by shining non-thermal laser light into the patient's eye. Once activated, Visudyne affects the abnormal blood vessels, resulting in a cessation of growth of these abnormal blood vessels and stabilization of the corresponding vision loss.Visudyne therapy does not appear to damage normal retina vessels on fluorescein angiography, even after multiple treatments.
Visudyne therapy involves the use of a specifically designed laser that produces the low level, non-thermal 689 nm light required to activate the drug. These lasers have been developed by two of the world's leading laser companies, Coherent Inc. (Nasdaq: COHR - news), based in California, and The Carl Zeiss Group, based in Germany.
About the Companies
CIBA Vision and QLT are co-developing Visudyne therapy for the treatment of wet AMD and various other ocular conditions. Upon commercialization, CIBA Vision will market the product worldwide, while QLT will be responsible for manufacturing.
Visudyne therapy is protected by a series of US and foreign-issued patents that cover the composition of matter, formulations and manufacturing, and the method of use in treating AMD and other conditions.
With worldwide headquarters in Atlanta, Georgia, CIBA Vision is a global leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products, intraocular lenses, and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. For more information, visit the CIBA Vision website at cibavision.com .
CIBA Vision is the eye care unit of Novartis AG, a world leader in Life Sciences with core businesses in Healthcare, Agribusiness and Consumer Health (Nutrition and Self-Medication). In 1998, Novartis Group sales were CHF 31.7 billion, of which CHF 17.5 billion were in Healthcare, CHF 8.4 billion in Agribusiness and CHF 5.8 billion in Consumer Health. The group annually invests more than CHF 3.7 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about
82,000 people and operates in over 140 countries around the world.
QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic therapy, an emerging field of medicine utilizing light-activated drugs in the treatment of disease. QLT's innovative science has advanced photodynamic therapy beyond applications in cancer towards potential breakthrough treatments in ophthalmology and autoimmune disease.
In addition to Visudyne therapy, QLT's portfolio of products include PHOTOFRIN® (porfimer sodium), the world's only approved photodynamic therapy drug, used in the treatment of various cancers throughout North America, Japan and Europe.
Visudyne(TM) is a trademark of Novartis AG.
PHOTOFRIN® is a registered trademark of QLT PhotoTherapeutics Inc.
QLT PhotoTherapeutics Inc. is listed on The NASDAQ Stock Market under the trading symbol ''QLTI'' and on The Toronto Stock Exchange under the trading symbol ''QLT''. |
