Hi guys, this is part of the news release today. Ally ooop!
FDA ADVISORY PANEL RECOMMENDS APPROVAL OF VISUDYNE
THERAPY FOR WET AMD
QLT and CIBA Vision Advance to Final Stage of Approval Process
For Immediate Release November 17, 1999
ATLANTA, GEORGIA and VANCOUVER, CANADA-The Ophthalmic Drugs Subcommittee of the U.S. Food and Drug Administration (FDA) today recommended approval of Visudyne (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," s aid 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."
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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. (NASDAQ:COHR), 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. |
