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Novartis Ophthalmics

New Data From Visudyne® 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® 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
About VIM
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.
About VIP
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.
About AMD
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.
About Visudyne
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® 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
References
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
   The company news service from the London Stock Exchange

Contact:

Novartis Ophthalmics, Worldwide
Bulach, Switzerland
Kathrin Wyss
Mobile: +41/79/616'05'12
Fax +41/1/862'03'86

QLT Inc.
Vancouver, BC
Therese Hayes/Tamara Hicks
Tel. +1/800-663-5486
Fax +1/604-707-7000

Novartis Ophthalmics AG
Visudyne Communications
CH-8180 Bulach
Switzerland
Tel. +41/1/864'16'19
Fax +41/1/862'03'86
Internet: www.novartis.com