6-month results from EVEREST study evaluating Visudyne(R) therapy in patients with polypoidal choroidal vasculopathy
09 Décembre 2009 - 1:00PM
PR Newswire (US)
VANCOUVER, Dec. 9 /PRNewswire-FirstCall/ -- QLT Inc. (NASDAQ: QLTI;
TSX: QLT) ("QLT" or the "Company") welcomed the 6-month results
from the Novartis-sponsored EVEREST study which were presented
during a scientific review today by Novartis in Basel, Switzerland.
EVEREST is the first multi-center, double-masked, indocyanine green
angiography (ICG-A) -guided randomized controlled trial with an
angiographic treatment outcome designed to assess the effect of
Visudyne(R) (verteporfin photodynamic therapy) alone or in
combination with Lucentis(R) (ranibizumab) compared with Lucentis
alone in patients with symptomatic macular polypoidal choroidal
vasculopathy (PCV). A total of 61 PCV patients of Asian ethnicity
from 5 countries (Hong Kong, Taiwan, Korea, Thailand, and
Singapore) participated in the study. The key results from EVEREST
include: - Complete Polyp Regression (primary endpoint): Visudyne
combination with Lucentis and Visudyne monotherapy showed a
significantly higher proportion of patients with complete polyp
regression at month 6 than the Lucentis monotherapy group. Complete
polyp regression was achieved in 77.8% of patients who received the
Visudyne - Lucentis combination, while 71.4% of Visudyne
monotherapy patients had complete regression compared with 28.6% of
patients in the Lucentis monotherapy group (p=0.0018 for
combination, p=0.0037 for Visudyne vs. Lucentis). - Best Corrected
Visual Acuity from baseline to Month 6: On average, patients in all
groups gained vision, with patients in the combination group
achieving the highest gain (+10.9 letters from baseline). Lucentis
monotherapy patients gained +9.2 letters, and Visudyne monotherapy
patients +7.5 letters. Differences between the groups are not
statistically significant. - All therapies were well tolerated and
the safety findings were consistent with the established safety
profiles of Visudyne and Lucentis. "EVEREST suggests that in a
majority of patients, Visudyne therapy, with or without Lucentis,
may lead to complete regression of the polyps that can cause vision
loss in patients with PCV, a potentially devastating eye disease,"
said Bob Butchofsky, President and Chief Executive Officer of QLT.
"While published case studies had implied this effect, EVEREST is,
to our knowledge, the first randomized, controlled trial designed
to corroborate such observations." About EVEREST EVEREST is the
first multicenter, double-masked, ICG-Angiography-guided randomized
controlled trial with an angiographic treatment outcome (6 month)
designed to assess the effect of Visudyne alone or in combination
with Lucentis vs. Lucentis alone in patients with symptomatic
macular PCV. EVEREST was solely sponsored by Novartis and data are
property of Novartis Pharma AG, Basel. A total of 61 PCV patients
of Asian ethnicity from 5 countries (Hong Kong, Taiwan, Korea,
Thailand, and Singapore) were randomly assigned to: - Visudyne +
Lucentis combination (n=19) or - Visudyne monotherapy (n=21) or -
Lucentis monotherapy (n=21) Visudyne was administered at standard
fluence (600 mW/cm2). Patients were assessed monthly. Starting at
Month 3, patients were treated on an as-needed basis according to
pre-specified study specific re-treatment criteria (complete polyp
regression, leakage as determined by fluorescein angiography and
5-letter visual acuity loss from best measured value, according to
treatment intervals specified in the European Visudyne and Lucentis
labels). About PCV Polypoidal choroidal vasculopathy (PCV) was
first described by Yanuzzi et al in 1990 (Yanuzzi et al.. Retina
1990; 10(1):1-8). PCV lesions have been found in patients of many
different racial backgrounds but are known to selectively affect
patients of pigmented races. PCV lesions have been found to account
for 23-55% of patients with presumed neovascular AMD in Asian
countries as opposed to patients of Caucasian origin where PCV
lesions have been found in roughly 8-13% of patients with presumed
neovascular AMD (Sho et al. Arch Ophthalmol 2003) (Ciardella et al.
Surv Ophthalmol. 2004;49:25-37). PCV lesions are differentiated
clinically by their characteristic orange-red polyp-like structures
that contain branching inner choroidal vascular networks of blood
vessels. About half of patients who have PCV lesions develop
significant vision loss, while good vision is preserved in the
others (Uyama et al. Am J Ophthalmol 2002;133:639-648). Indocyanine
green angiography (ICG-A) is considered the gold standard for the
diagnosis of PCV as it allows for the physician to identify these
characteristic vascular networks originating from macular choroidal
vessels. About Visudyne Visudyne therapy is a two-step procedure
involving the intravenous administration of the drug into the
patient's arm. A non-thermal laser light is then shone into the
patient's eye to activate the drug. This produces a reaction that
closes the abnormal leaky vessels, resulting in a stabilization of
the corresponding vision loss. Visudyne is approved worldwide for
the treatment of a form of wet AMD, the leading cause of legal
blindness in people over the age of 50, and has been used in more
than two million treatments worldwide. Visudyne is commercially
available in more than 80 countries for the treatment of
predominantly classic subfoveal CNV. In addition, over 60 countries
have approved Visudyne to treat one or more other macular
neovascular conditions such as minimally classic and occult with no
classic AMD lesions, pathologic myopia and presumed ocular
histoplasmosis. Visudyne is generally well tolerated and has a well
established safety profile. The most commonly reported side effects
include injection site reactions and visual disturbances. In
addition, some patients experienced back pain, usually during the
infusion. Using the approved light dose of 50 J/cm2 between 1% and
5% of patients experienced a substantial decrease in vision in the
first 7 days with partial recovery in some patients. After
treatment, patients should avoid direct sunlight for five days to
prevent sunburn. People with porphyria should not be treated with
Visudyne. About combination of Visudyne PDT and Lucentis The
combination of Visudyne and Lucentis is not approved by the
regulatory authorities for the treatment of wet AMD. About QLT QLT
Inc. is a pharmaceutical company dedicated to the development and
commercialization of innovative therapies for the eye. We are
focused on our commercial product Visudyne for the treatment of
wet-AMD, and the development of drugs to be delivered in our
proprietary punctal plug devices. For more information, visit our
website at http://www.qltinc.com/. Lucentis(R) is a registered
trademark of Genentech, Inc. Visudyne(R) is a registered trademark
of Novartis AG. QLT Inc. is listed on The NASDAQ Stock Market under
the trading symbol "QLTI" and on the Toronto Stock Exchange under
the trading symbol "QLT." Forward-Looking Statements Certain
statements in this press release constitute "forward looking
statements" of QLT within the meaning of the Private Securities
Litigation Reform Act of 1995 and constitute "forward looking
information" within the meaning of applicable Canadian securities
laws. Forward looking statements include, but are not limited to:
our statements concerning the potential of Visudyne therapy, with
or without Lucentis, to lead to complete regression of polyps in
patients with PCV; any future expectations concerning
Visudyne-Lucentis combination therapy; and statements which contain
language such as: "assuming," "prospects," "future," "projects,"
"believes," "expects" and "outlook." Forward-looking statements are
predictions only which involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from those expressed in such statements. Many
such risks, uncertainties and other factors are taken into account
as part of our assumptions underlying these forward-looking
statements and include, among others, the following: the results of
clinical studies may not result in increased use of Visudyne;
uncertainties relating to the timing and results of the clinical
development and commercialization of our products and technologies
(including Visudyne monotherapy, Visudyne-Lucentis combination
therapy and our punctal plug technology) and the associated costs
of these programs; the timing, expense and uncertainty associated
with the regulatory approval process for products; uncertainties
regarding the impact of competitive products and pricing; risks and
uncertainties associated with the safety and effectiveness of our
technology; risks and uncertainties related to the scope, validity,
and enforceability of our intellectual property rights and the
impact of patents and other intellectual property of third parties;
and general economic conditions and other factors described in
detail in QLT's Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q and other filings with the U.S. Securities and Exchange
Commission and Canadian securities regulatory authorities. Forward
looking statements are based on the current expectations of QLT and
QLT does not assume any obligation to update such information to
reflect later events or developments except as required by law.
DATASOURCE: QLT Inc. CONTACT: QLT Inc. Media Contact: Vancouver,
Canada, Karen Peterson, Telephone: (604) 707-7000 or
1-800-663-5486, Fax: (604) 707-7001, ; The Trout Group Investor
Relations Contact: New York, USA, Christine Yang, Telephone: (646)
378-2929, ; or Marcy Nanus, Telephone: (646) 378-2927,
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