UPDATE NOTICE: Since this press release was published in April 2000, Visudyne™ therapy for AMD was approved for marketing in all countries listed in this article, except for India. In August 2001, the FDA also approved Visudyne™ therapy for the treatment of occult subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD). That approval was later rescinded by the FDA pending further study, but on April 1, 2004, the Centers for Medicare and Medicaid Services (CMS) implemented its decision to also provide coverage for PDT to patients who have occult and minimally classic lesions that are four disc areas or less in size and show evidence of recent disease progression. This includes the majority of patients with all forms of "wet" AMD. Medicare already offers coverage for PDT in AMD patients with predominantly classic lesions. In August, 2002, Visudyne therapy for occult macular degeneration was granted marketing authorization in European countries by the European Commission (EMEA).
By early 2002, submissions had been filed with regulatory agencies in the European Union, Canada, Australia and New Zealand for the occult form of AMD.
On October 29, 2004, QLT, Inc. (the makers of Visudyne) reported that the drug has been approved in over 50 countries for extended indications, including occult CNV, in the European Union, Japan, Australia and New Zealand, CNV due to pathologic myopia in the United States, Canada and the European Union and CNV due to presumed ocular histoplasmosis syndrome in the United States.
Atlanta and Vancouver, British Columbia, April 12, 2000/PRNewswire/ -- CIBA Vision, the eye care unit of Novartis, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI; Toronto) announced today that the U.S. Food and Drug Administration (FDA) has approved Visudyne™ (verteporfin for injection) therapy for the treatment of the wet form of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world.
Specifically, the FDA approved Visudyne therapy for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV). Medical experts estimate that of the 500,000 new patients that develop wet AMD every year around the world, 40-60% will develop predominantly classic lesions during the progression of their disease. Patients with this condition lose their ability to read, drive and recognize faces in as little as two months to three years.
``The approval of Visudyne therapy to treat AMD is a landmark event within the field of ophthalmology. As the first approved drug therapy for this devastating condition, Visudyne provides new hope to many of the 200,000 Americans who lose their vision from wet AMD every year,'' said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit. ``This therapy will be available to eye care professionals and their patients across the country within 24 hours.''
``This is a proud day for all QLT and CIBA Vision employees,'' said Dr. Julia Levy, President and Chief Executive Officer of QLT. ``We have worked toward this day since we treated the first AM D patient with Visudyne therapy in clinical trials just five years ago. The relatively short development time from discovery to market illustrates not only QLT's capabilities but the importance of having a committed partner like CIBA Vision.''
The approval was based on 12-month data from two 24-month randomized, double-masked, placebo-controlled Phase III trials known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation. The results of the TAP Investigation were published in the October 1999 issue of Archives of Ophthalmology, a leading international medical journal. The primary finding of these trials showed that in 243 patients with predominantly classic CNV, vision remained stable or improved in 67% of patients treated with Visudyne therapy compared to 39% of patients on placebo (p<0.001).
Top-line data has recently been released showing that the beneficial effect and the favorable safety profile of Visudyne therapy observed at the 12-month time point has been maintained out to two years with fewer treatments required in the second year.
Visudyne therapy is currently approved and commercially available in Switzerland and Malta. Regulatory applications are pending in the European Union, Canada, Norway, Iceland, Australia, New Zealand, Brazil, Argentina, India, among others. While regulatory reviews are ongoing, Visudyne is currently being made available under certain expanded access programs in more than 25 countries.
``With this effective new therapy now available in the United States, it is increasingly important to heighten the awareness of this condition among the general public,'' said Robert Gray, CEO of the Foundation Fighting Blindness. ``Despite the high prevalence of AMD, according to a recent study, only 30% of American adults are familiar with the condition.''
``We encourage everyone over the age of 50 to see their eye care professional once a year for a routine check up,'' he added.
Patients and physicians seeking additional information may view the Visudyne web site at www.visudyne.com or call 1-800-821-2450 within North America.
Wet AMD is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow across the central part of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision. Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, Visudyne is injected intravenously into the patient's arm. The drug is then activated by shining non-thermal laser light into the patient's eye.
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 Zeiss Humphrey, based in California, and comprise the two device PMAs approved today in conjunction with the NDA.
Visudyne is being co-developed for ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. CIBA Vision markets the product worldwide while QLT retains responsibility for manufacturing the product.
Visudyne therapy is protected by a series of U.S. 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, USA, CIBA Vision is a global leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care prod ucts and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries. For more information, you are invited to visit the CIBA Vision web site at www.cibavision.com.
CIBA Vision is the eye care unit of Novartis AG, a world leader in health care with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested more than CHF 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000.
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 various cancers towards breakthrough treatments in ophthalmology and auto immune disease. For more information, you are invited to visit QLT's web site at www.qltinc.com.
Visudyne™ is a trademark of Novartis AG
Please Note:
Outside of the U.S., Switzerland, and Malta, the treatment of wet AMD with Visudyne therapy is currently investigational. Only patients who are currently enrolled in clinical trials sponsored by QLT and CIBA Vision or under expanded access programs meeting local requirements in certain other countries, are eligible for treatment at this time.
Patients and practitioners seeking additional information may view our web site at www.visudyne.com or call 1-800-821-2450. 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''.
The foregoing information contains forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Such factors include: risks associated with the commercialization of Visudyne? therapy; dependence on corporate relationships; manufacturing uncertainties; uncertainty of pricing and reimbursement; uncertainties relating to clinical trials and product development; the Company's history of operating losses and uncertainty of future profitability; competition; rapid growth; uncertainty regarding patents and proprietary rights; product liability claims and insurance; no assurance of regulatory approval; government regulation; uncertainty of access to capital; anti-takeover provisions; and volatility of common share price; among others, all as described in the Company's Annual Information Form on Form 10-K.
CIBA Vision contact: Kristie Madara CIBA Vision Corporate Communications 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Telephone: (678) 415-3646 Fax: (678) 415-3592
For more information, see the MD Support Glossary and read "Photodynamic Therapy" in the MD Support Library.
Visit the CIBA Vision web site or the Visudyne therapy web site.
QLT PhotoTherapeutics Inc. contacts: Elayne Wandler or Tamara Hicks QLT Corporate Communications and Investor Relations, 520 West 6th Avenue Vancouver, BC Canada V5Z 4H5. Telephone: 1-800-663-5486, (604) 872-7881. Fax: (604) 873-0816.
For more information, visit the QLT web site.