And this version, from QLT:
ATLANTA and VANCOUVER, Nov. 17 /CNW-PRN/ - The Ophthalmic Drugs Subcommittee of the U.S. Food and Drug
Administration (FDA) today recommended approval of Visudyne(TM) (verteporfin for injection) therapy for the treatment of
wet age-related macular degeneration (AMD), the leading cause of blindness among people over the age of 50. Both the panel
and the FDA concluded that Visudyne therapy was most appropriate for patients with predominantly classic subfoveal
choroidal neovascularization (CNV), the indication proposed by co-developers CIBA Vision, the eye care unit of Novartis, and
QLT PhotoTherapeutics Inc.
Typically, the subcommittee, a panel of expert consultants to the FDA, would be asked to vote on whether or not they
recommend a product be approved. In the case of Visudyne, the FDA did not ask the panel to formally vote on approvability,
but sought guidance on efficacy and confirmation of safety and product labeling. At the conclusion of the hearing, the panel
members voluntarily expressed their view that the therapy should be approved.
The panel's conclusions will be taken into consideration by the FDA as it completes its review of the New Drug Application
(NDA) for Visudyne therapy, which was submitted on August 16, 1999. The FDA is expected to make a final decision
regarding the approval of the Visudyne application on or before February 2, 2000. Regulatory applications are also pending in
the European Union, Canada, Switzerland, Norway, Iceland, Australia and New Zealand.
The panel and the FDA concurred that Visudyne therapy is generally safe and well-tolerated, with minimal adverse events
relating to treatment.
Currently, only 10 - 15% of the estimated 500,000 patients who develop wet AMD worldwide every year are eligible for
existing treatments. Medical experts estimate that between 40-60% of all wet AMD cases will develop predominantly classic
lesions as the disease progresses.
''Today's endorsement moves us one step closer to providing a much needed treatment for the many patients suffering from the
devastating effects of wet AMD,'' said Luzi von Bidder, President of CIBA Vision's worldwide Ophthalmics Business Unit.
''We await the FDA's final decision and with it, the opportunity to introduce this promising new therapy early in the New Year.''
''We are extremely encouraged about today's outcome,'' said Dr. Julia Levy, President and Chief Executive Officer of QLT.
''Not only does this recommendation have significant implications for QLT and CIBA Vision, but it has the potential to improve
the lives of so many people around the world.''
About AMD and Visudyne therapy
Wet AMD typically destroys central vision, which is necessary for reading, driving, and recognizing faces. The condition is
characterized by the formation of abnormal blood vessels (choroidal neovasculature or CNV) that grow across the central part
of the retina, called the macula. These vessels leak fluid and eventually cause scar tissue, which destroys central vision in as little
as 2 months to 3 years.
Visudyne 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.
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. It 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 affects the abnormal blood vessels, resulting in a cessation of growth of
these abnormal blood vessels and stabilization of the corresponding vision loss. Visudyne therapy does not appear to damage
normal retinal vessels using a diagnostic method called fluorescein angiography, even after multiple treatments.
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., based in
California, and the Carl Zeiss Group, based in Germany, and comprise the two device PMAs submitted in conjunction with the
NDA.
Additional Phase III trials are being conducted to determine the effectiveness of Visudyne therapy in patients with an earlier
stage of AMD who were originally excluded from the initial Phase III investigation as well as patients with a similar but distinct
condition of abnormal blood vessels associated with progressive near-sightedness known as pathologic myopia.
Visudyne therapy is protected by a series of U.S. and foreign issued patents which cover the composition of matter,
formulations and manufacturing, and the method of use in treating AMD and other conditions.
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 and ophthalmic
pharmaceuticals. CIBA Vision products are available in more than 70 countries. For more information, you are invited to visit
the CIBA Vision website at www.cibavision.com.
CIBA Vision is the eye care unit of Novartis AG, a world leader in Life Sciences with core businesses in Healthcare,
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 Healthcare, 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 R&D. Headquartered in Basel, Switzerland, Novartis employs about
82,000 people and operates in over 100 countries around the world.
|
