New Data From Visudyne(R) In Minimally Classic(VIM) Trial Confirm Importance Of Lesion Size In The Treatment Of "Wet" AMD
Madrid (ots) - New data from the VIM study presented today at the annual Congress of the European Society of Ophthalmology (SOE) demonstrate that Visudyne(R) therapy benefited patients with smaller base line lesions* in minimally classic "wet" AMD, a form of AMD previously considered untreatable.1 Visudyne is the only drug approved for other forms of wet AMD, the leading cause of blindness in people over the age of 50.
Furthermore, these twelve-month data showed that patients treated with Visudyne had an increased chance of their vision stabilising or improving compared with placebo. Visudyne treated patients also had a reduced risk of developing predominantly classic CNV, considered a more aggressive form of the disease.
"The results of the VIM trial are promising." said Jordi Mones, Professor of Ophthalmology, Barcelona Institute of Ocular Microsurgery, Spain. "This study, designed to investigate the vision outcomes in minimally classic lesions with smaller lesion size, reinforces the ophthalmic community's widely held belief that lesion size is equally as important as lesion composition in influencing treatment outcomes in patients with minimally classic or occult AMD. These observations will simplify current management of AMD and we expect further demonstration in ongoing prospective studies."
Retrospective analyses of the data from patients with occult AMD in the Verteporfin in Photodynamic Therapy trial (VIP) further emphasise the importance of lesion size. The results showed a correlation between lesion size, baseline visual acuity and vision outcomes. Patients with smaller lesions benefited the most from Visudyne therapy compared with the group whose lesions were larger. Compared to patients with larger lesion, these patients demonstrated a statistically significant improvement in, and stabilisation of vision and showed similar treatment outcomes as for predominantly classic lesions.
* Lesion size of less than 6 Disc Areas
Gisele Soubrane, Professor and chair in Ophthalmology, Eye University Clinic of Creteil, France said: "Retrospective analysis of the VIP data showed that Visudyne is even more effective in patients with smaller occult AMD lesions. Prompt treatment with Visudyne, now widely accepted to be the standard of care in wet AMD, is an important factor in stabilising and maintaining vision in the long term, thereby preserving patient quality of life."
Novartis Ophthalmics and QLT, Inc., partners in developing Visudyne, are working to enhance the benefits offered to patients by this therapy through a comprehensive, on-going clinical trial program involving more than 1,000 patients. The Helen Keller Foundation for Research and Education has awarded both companies with the prestigious Helen Keller Prize for Innovation in Eye Care, in recognition of their development of photodynamic therapy for the treatment of wet AMD, bringing hope to individuals facing blindness, and for being a significant stimulus for the development of treatment for all forms of retinal degeneration. The award was presented at an exclusive ceremony held during the 2003 Association for Research in Vision and Ophthalmology (ARVO) annual meeting. Fort Lauderdale, Florida.
Notes to Editors
The multicenter VIM Trial assessed the potential benefit of Visudyne therapy in 117 AMD patients with minimally classic CNV randomized to one of three treatment arms: placebo; Visudyne standard fluence (light intensity) (600 mW/cm2); or Visudyne reduced fluence rate (300 mW/cm2). At follow-up, results suggested that Visudyne therapy at either light fluence rate was beneficial in terms of vision outcomes: patients had an increased chance of stable or improved vision. Patients in the VIM Trial will continue to be followed through 24 months.
The VIP Trial, a phase IIIb clinical trial, consisted of an AMD and a pathologic myopia arm. The study included 258 patients with subfoveal occult without classic CNV, who had recent disease progression. The VIP Trial was conducted at 28 clinical sites in Canada, United States, United Kingdom, France, Germany, Austria, Italy, Spain, Sweden and Switzerland between February 1998 and September 2000.
AMD is the leading cause of legal blindness in people over the age of 50. Its associated vision loss has been shown to significantly decrease quality of life. Everyday tasks such as driving and walking can be severely affected. Awareness of the condition and treatment in the initial stages of the disease are essential for patients to take the necessary steps that lead to diagnosis and early treatment to halt progression of AMD.
Vision loss from AMD occurs in two forms: dry and wet. The dry form is associated with atrophic cell death of the central retina. The wet form is caused by growth of abnormal blood vessels (CNV) under the central part of the retina or macula. These vessels leak fluid and blood and cause 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 often appears as hyperfluorescence in the late-phase frames of the angiogram.
Visudyne therapy is a two-step procedure. Following intravenous administration, Visudyne is activated by a non-thermal laser light. The process is known as photodynamic therapy. Visudyne selectively targets and immediately occludes abnormal blood vessels under the retina, resulting in a reduction in their growth, without affecting healthy retina tissue. This, in turn, stops the leakage associated with wet AMD. Through its unique mode of action, Visudyne provides the chance to reduce the risk of visual acuity loss, to stabilize contrast sensitivity and thereby preserve quality of vision long term.
Visudyne is the only drug approved for the treatment of some forms of wet AMD, the leading cause of blindness in people over the age of 50, and has been used in more than 250,000 patients worldwide. Recent clinical data show evidence in its efficacy and safety though a treatment period of up to 5 years. Visudyne is
commercially available in more than 70 countries for the treatment of predominantly classic subfoveal CNV and in over 36 countries for occult subfoveal CNV caused by AMD. It is also approved in more than 55 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, back pain, blurring, decreased sharpness and gaps in vision, and in one - five per cent of patients, a substantial decrease in vision with partial recovery. After treatment, patients should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated. For more information visit www.visudyne.com.
Visudyne(R) is a trademark of Novartis AG.
The foregoing press release contains forward-looking statements that can be identified by terminology such as "extremely promising", "expect further demonstration", or by discussions regarding the evaluation of early trial data or potential new indications or treatment methods 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; and additional information and other factors as described in detail in Novartis AG's Form 20-F, and other filings with the US Securities and Exchange Commission.
Background on Novartis
Novartis Ophthalmics: With worldwide 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 age-related macular degeneration, eye inflammation, glaucoma, 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 products are made 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 http://www.novartis.com.
QLT Inc. (Nasdaq:QLTI; TSE: QLT) is a global pharmaceutical company specializing in the discovery, development and commercialization of innovative therapies to treat cancer, eye diseases and niche areas for which treatments can be marketed by a specialty sales force. 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. For more information, visit our web site at www.qltinc.com
1 Bressler N et al, A Phase II Placebo-Controlled, Double-Masked, Randomized Trial - Verteporfin in Minimally Classic CNV due to AMD (VIM), ARVO Annual Meeting, Ft. Lauderdale, Florida, May 4-8, 2003. Abstract.
This information is provided by RNS