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Press Releases
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| Long-Term Benefit of Visudyne® Therapy for Wet Age-Related Macular Degeneration Published in Archives of Ophthalmology |
POSITIVE 36- AND 48-MONTH TRIAL EXTENSION RESULTS SHOW VISION BENEFIT OVER TIME IN PREDOMINANTLY CLASSIC SUBFOVEAL WET AMD
FOR IMMEDIATE RELEASE OCTOBER 21, 2002
VANCOUVER, CANADA and BASEL, SWITZERLAND—Data published in the current issue of Archives of Ophthalmology shows that visual outcomes remain stable during the third year of Visudyne® (verteporfin) therapy in patients treated for choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50. The research was sponsored by QLT Inc. (NASDAQ: QLTI; TSX: QLT) and Novartis Ophthalmics, the eye health unit of Novartis AG (NYSE: NVS) and is based on an open-label extension of the two pivotal Phase III clinical trials, the Treatment of AMD in Photodynamic Therapy (TAP) Investigation.
The average visual acuity of patients originally assigned to Visudyne with predominantly classic subfoveal CNV caused by AMD remained stable between the 24- and 36-month follow-up as reported in the publication. Analysis of 48-month results recently presented at the Joint Meeting of the Retina Society and Vitreous Society in San Francisco, confirmed the maintenance of vision over this longer period.
“For a chronic, often progressive disease such as the wet form of advanced AMD, evidence of longer term maintenance of vision through three and four years is very good news for both patients and physicians. We now know that by treating with Visudyne therapy today we are not only helping our patients reduce their risk of vision loss, but also that visual loss does not appear to continue indefinitely. The chance of additional vision loss appears unlikely to occur in a patient beyond two years after the onset of therapy,” said Dr. Neil Bressler, chair of the Visudyne Study Advisory Group, retinal specialist and the James P. Gills Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore, Maryland, USA.
In the 48-month follow-up, the number of Visudyne treatments required in the ongoing trial was just over 7 with approximately half the patients needing a treatment in the fourth year to maintain their vision. Furthermore, the favorable safety profile previously demonstrated with Visudyne continued throughout the 36- and 48-month analyses.
Visudyne therapy is a relatively painless two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light. This process is known as photodynamic therapy. Visudyne selectively targets abnormal blood vessels on the retina, resulting in a reduction in their growth, without affecting normal/healthy retina tissue. This in turn stops the leakage associated with wet AMD.
Following the conclusion of the TAP Investigation, consisting of two 2-year randomized, double-masked, placebo-controlled trials, 78% of the 609 patients originally included, were offered Visudyne therapy in an ongoing 3-year, open-label extension trial regardless of whether they previously received Visudyne or a placebo in the original study.
About AMD
AMD and its associated vision loss have been shown to decrease patient quality of life significantly. Everyday tasks such as driving and walking can be severely affected. Awareness of the condition and treatment in the early stages of the disease are essential in order to help patients take the necessary steps to visit their physician and begin therapy to halt progression of AMD. Through its unique mode of action, Visudyne provides the chance to preserve vision long-term.
AMD is caused by a growth of abnormal blood vessels (CNV) under the central part of the retina or macula and occurs in two forms, dry and wet AMD. In the wet form, the vessels leak fluid and blood that lead to the development of scar tissue that destroys the central retina. This results in a deterioration of sight over a period of months to years. “Occult” and “classic” are terms used to describe the different patterns of CNV leakage as seen on fluorescein angiography. Classic CNV appears as a well-demarcated area of hyperfluorescence in the early-phase frames of the angiogram. The boundaries of occult CNV are often poorly defined or difficult to demarcate and hyperfluorescence appears in the late-phase frames of the angiogram.
About Visudyne
Visudyne therapy, the only drug approved for the treatment of some forms of wet AMD, has treated over 200,000 patients worldwide. Visudyne is commercially available in more than 65 countries for the treatment of predominantly classic subfoveal CNV and in 24 countries for occult subfoveal CNV caused by AMD. It is also approved in over 45 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In some countries Visudyne is also approved for presumed ocular histoplasmosis or other macular diseases.
Visudyne is generally well tolerated and has an excellent safety profile. Potential side effects include injection site reactions, headaches, back pain, blurring, decreased sharpness and gaps in vision, and in 1-5% of patients a substantial decrease in vision with partial recovery in some patients. People should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated. For more information, visit www.visudyne.com.
Note to editors
Funding for the study described was provided by QLT Inc. and Novartis Ophthalmics. Dr. Bressler has been paid as a consultant to both companies. The terms of this agreement are being managed by the Johns Hopkins University in accordance with its conflict of interest policies.
The foregoing press release contains forward-looking statements that can be identified by terminology such as “preserve their sight for the future,” or by discussions regarding potential new indications for existing products. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results and assumptions to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, but are not limited to: risks associated with the development and commercialization of the treatment, including uncertainties relating to manufacturing, clinical trials, registration, pricing and reimbursement; patient and physician demand for the treatment; competition; any uncertainty regarding patents and proprietary rights; outcome of litigation claims, product liability claims and insurance; government regulation; anti-takeover provisions; dependence on corporate relationships; volatility of share prices; QLT Inc’s rapid growth, its history of operating losses and uncertainty of future profitability, its access to capital; and additional information and other factors as described in detail in QLT Inc.’s Annual Information Form on Form 10-K and recent and forthcoming quarterly reports on Form 10Q, and Novartis AG’s Form 20-F, and other filings with the US Securities and Exchange Commission and Canadian Securities Regulatory authorities.
Background on Novartis Ophthalmics and QLT
QLT Inc. (NASDAQ: QLTI; TSE: QLT) is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies to treat cancer, eye diseases and immune disorders. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialized two products to date, including Visudyne therapy, which is the most successfully launched ophthalmology product ever.
Novartis Ophthalmics: With world-wide headquarters in Bulach, Switzerland, Novartis Ophthalmics is a global leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of glaucoma, age-related macular degeneration, eye inflammation, ocular allergies and other diseases and disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. The North American headquarters is based in Atlanta, Georgia. Novartis Ophthalmics has production sites in Switzerland, France and Canada. For more information, visit www.novartisophthalmics.com or www.novartisophthalmics.com/us.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information please consult www.novartis.com.
Visudyne is a registered trademark of Novartis AG.
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QLT Inc.
Vancouver, Canada
Therese Crozier or Tamara Hicks
t 1.604.707.7000
f 1.604.707.7001
Novartis Ophthalmics, North America
Duluth, Georgia, USA
Jan McClure
t 1.770.905.1020
f 1.770.905.1510
Novartis Ophthalmics, Worldwide
Bulach, Switzerland
Kathrin Wyss
t +41 1 864 16 19
f +41 1 862 03 86
QLT Inc. is listed on the Nasdaq Stock Market under the trading symbol "QLTI" and on the Toronto Stock Exchange under the trading symbol "QLT." |
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