This would be a good time for one of my favorite little poems, entitled "I am monarch of all I survey......."
but I'll spare you that. Instead I'll just post to0day's QLT release.
QLT and CIBA Vision seeking approval of Visudyne therapy
P.S For those interested International Curator listed on Toronto looks as if it might be being prepared for some activity by the Lundins. AGM on WED and NR to-day also on their Crowsnest gold property. Make like a chicken and go Cheep Cheep Cheep.
QLT PhotoTherapeutics Inc QLT
Shares issued 28,385,597 Aug 13 close $116.00
Mon 16 Aug 99 News Release
Dr. Julia Levy reports
CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT
PhotoTherapeutics Inc. have submitted a new drug application (NDA) to the
United States Food and Drug Administration (FDA) seeking marketing
clearance for Visudyne therapy for the treatment of wet age-related macular
degeneration (AMD), the leading cause of blindness in people over the age
of 50 in the western world.
The specific indication requested is for the treatment of AMD in patients
with predominantly classic subfoveal choroidal neovascularization, the most
aggressive cause of vision loss associated with the disease and for which
Visudyne showed a dramatic benefit. The companies have requested a priority
review within a six-month period as there is no current satisfactory
treatment for the majority of patients with wet AMD.
Wet AMD is characterized by the formation of abnormal leaky blood vessels
(choroidal neovasculature) that grow across the central part of the retina,
called the macula. The wet form represents an estimated 15 per cent of all
AMD cases but accounts for approximately 90 per cent of the severe vision
loss associated with the disease. Currently available treatments are
limited in effectiveness and only applicable for approximately 10 per cent
to 20 per cent of the 500,000 new cases of wet AMD that develop worldwide
every year.
"On the heels of filing in the European Union last week, this United States
submission underscores our commitment to bringing this treatment as quickly
as possible to patients throughout the world affected by this deleterious
disease," said Dr. Julia Levy, president and chief executive officer of
QLT.
"There is tremendous demand for more effective treatments for macular
degeneration," said Luzi von Bidder, president of CIBA Vision's worldwide
Ophthalmics Business Unit. "The approval of Visudyne therapy has the
potential to improve the lives of many thousands of people."
The submission is 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 trials are
taking place at 22 centres in North America and Europe and have enrolled a
total of 609 patients. At the 12-month follow-up visit, among the 243
patients in the trial with predominantly classic lesions, those treated
with Visudyne therapy exhibited a large treatment benefit. Specifically,
based on an intent-to-treat analysis, vision was stable (defined as a loss
of less than three lines of vision on a standard eye chart) or improved in
67 per cent of these patients treated with Visudyne therapy, compared with
39 per cent of patients administered placebo. Accordingly, patients treated
with Visudyne therapy were 72 per cent more likely to retain their vision,
compared with the placebo group. These results were found to be
statistically significant in this population for each of the two studies,
as well as for the combined data (p is less than 0.001).
Statistically significant results on the combined data favouring Visudyne
therapy were also obtained for all secondary end points, including contrast
sensitivity and lesion growth. Visudyne therapy was more likely to confine
the growth of the lesion as well as maintain contrast sensitivity relative
to patients receiving placebo.
Results also showed that Visudyne therapy was well tolerated, with less
than 3 per cent of patients withdrawing from the study due to adverse
events. The majority of adverse events occurred in similar numbers among
the treatment and placebo groups. Those events that occurred more often
with Visudyne therapy were: reactions at the injection site that occurred
in 10 per cent more treated patients; transient mild to moderate decreased
vision that occurred in 2 per cent more treated patients; and
self-resolving photosensitivity reactions that usually occurred within 24
hours posttreatment in less than 3 per cent of treated patients.
A comprehensive analysis of the data is expected to be published in an
upcoming issue of a leading ophthalmic peer-reviewed journal. Top-line
results were presented at the Association for Research in Vision and
Ophthalmology meeting in Ft. Lauderdale, Fla. on May 11, 1999, and at the
European Society of Ophthalmology symposium in Stockholm on June 28, 1999.
About Visudyne therapy
Visudyne therapy can be performed in a doctor's office and is relatively
painless to the patient. Visudyne therapy consists of two stages. First,
Visudyne is injected intravenously into the patient's arm. It selectively
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 selectively affects the abnormal blood vessels and corresponding
vision loss. Visudyne therapy does not appear to damage normal retina
vessels on fluorescein angiography, even after multiple treatments.
Background on CIBA Vision
Visudyne therapy is being co-developed for various ocular conditions by
CIBA Vision Corporation and QLT PhotoTherapeutics Inc. Upon
commercialization, CIBA Vision will market the product worldwide while QLT
will be responsible for manufacturing.
Visudyne therapy is protected by a series of United States and foreign
issued patents which cover the composition of matter, formulations and
manufacturing, and the method of use in treating AMD and other conditions.
With worldwide headquarters in Atlanta, Ga., CIBA Vision is a global leader
in research, development and manufacturing of optical and ophthalmic
products and services, including contact lenses, lens care products, 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 life
sciences with core businesses in health care, 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 health care, 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 research and development.
Headquartered in Basel, Switzerland, Novartis employs about 82,000 people
and operates in over 100 countries around the world.
WARNING: The company relies on litigation protection for "forward-looking"
statements.
(c) Copyright 1999 Canjex Publishing Ltd. canada-stockwatch.com
Cheers
Trev. |
