Here's some more icing for the cake. :-) Outstanding statistics in the PR from Ciba and QLT. very encouraging results in extending Visudyne treatment to other conditions than ARMD.
Ian.
+++++++++++++++
Wednesday May 3, 10:35 am Eastern Time
Company Press Release
SOURCE: CIBA Vision; QLT PhotoTherapeutics Inc.
Visudyne Data Highlighted at the Association for Research in
Vision And Ophthalmology Annual Conference
FORT LAUDERDALE, Fla., May 3 /PRNewswire/ -- At the Association for Research in Vision and Ophthalmology (ARVO) annual conference held this week in Fort Lauderdale, investigators presented results from clinical trials studying Visudyne(TM) (verteporfin) therapy for the treatment of various eye diseases, including age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. ARVO is one of the major international vision conferences held every year.
The results included data that led the U.S. Food and Drug Administration (FDA) to approve Visudyne on April 12, 2000 as a treatment for AMD patients with predominantly classic subfoveal choroidal neovascularization (CNV).
``The approval of Visudyne represented a significant development in the treatment of retinal disease,'' said Dr. Philip Rosenfeld, retinal specialist at the Bascom Palmer Eye Institute, Miami. ``Prior to the approval of Visudyne, patients diagnosed with the wet form of AMD were faced with
limited treatment options.''
Some of the conclusions presented during the various sessions included:
* After two years of treatment Visudyne therapy was confirmed to be safe and effective.
* Approximately twice as many patients on Visudyne therapy with predominantly classic CNV -- the more aggressive type -- lost less than 3 lines of vision, or 15 letters, on a standard eye chart, compared to those patients on placebo (59.1% vs 31.3%, respectively) at 24 months.
* Patients averaged 5.5 treatments during a two year period.
* Visudyne therapy was well-tolerated. Injection site reactions and visual disturbances were the most frequently reported adverse events.
* Photosensitivity reactions, commonly associated with other photosensitizers, rarely occurred (0.6%) following Visudyne treatments.
This result was obtained in patients advised to stay out of direct sunlight and strong ambient light for 48 hours.
* Early detection and treatment is important since further analysis of results showed that the majority of vision loss in patients on placebo occurred in initial months and patients with smaller lesions, on average, had better visual outcomes.
* Visudyne is beneficial in ocular conditions involving neovascularization beyond AMD. Positive results were demonstrated with Visudyne in patients with CNV caused by pathologic myopia -- a degenerative form of near-sightedness that occurs among people over 30 years of age and promising results were obtained in patients with ocular histoplasmosis syndrome, a condition caused by a fungal infection of the retinal area.
``The results presented at this conference really validate the effectiveness of Visudyne therapy,'' said Dr. Mark Blumenkranz, Professor and Chairman of Ophthalmology at Stanford University and retinal specialist at the Zweng Memorial Retinal Research Foundation in Menlo Park.
``The sustained benefit shown in AMD and the initial positive results in patients with CNV due to pathologic myopia and ocular histoplasmosis make Visudyne an important tool for the retinal specialist in the fight against blindness.''
At 12 months, patients with CNV due to pathologic myopia showed a definite benefit from Visudyne therapy with respect to visual acuity, contrast sensitivity, lesion size, amount of leakage and other outcomes. Specifically, 86.4% of patients receiving Visudyne therapy lost less than 3 lines of vision, or 15 letters, on a standard eye chart, compared to 66.7% of patients administered a placebo. Patients in the study, whose average age was 50, received 3.5 treatments during the first 12 months of the study, on average.
In an open label safety study involving 26 patients with ocular histoplasmosis, visual acuity improved from baseline by an average of 1 line on a standard eye chart at 6 months with 27% of patients experiencing a visual acuity improvement of 3 lines or more. Visual acuity decreased by
less than 3 lines of vision in 88% of patients. At this time 27% of patients had visual acuity improvement of 3 lines or more while only 12% of patients had a decrease of 3 lines or more.
About AMD and Visudyne therapy
Wet AMD is characterized by the formation of abnormal blood vessels (choroidal neovascularization or CNV) that grow under 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. Visudyne is then activated by shining non-thermal laser light into the patient's eye.
Visudyne is being co-developed for ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics Inc. (Nasdaq: QLTI - news; Toronto: QLT - news). 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.
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.
Background on CIBA Vision and QLT
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 products, ophthalmic surgical 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 healthcare 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 autoimmune
disease. For more information, you are invited to visit QLT's web site at www.qltinc.com .
Visudyne(TM) is a trademark of Novartis AG
For more information, you are invited to visit the CIBA Vision web site at www.cibavision.com or the Visudyne therapy web site at
www.visudyne.com .
For more information, you are invited to visit the QLT web site at www.qltinc.com .
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.
SOURCE: CIBA Vision; QLT PhotoTherapeutics Inc. |
