6-month results from EVEREST study evaluating Visudyne(R) therapy in patients with polypoidal choroidal vasculopathy
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 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.
Source: QLT Inc.
CONTACT: QLT Inc. Media Contact: Vancouver, Canada, Karen
Peterson,
Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604)
707-7001,
kpeterson@qltinc.com; The Trout
Group Investor Relations Contact: New York,
USA, Christine Yang, Telephone: (646) 378-2929, cyang@troutgroup.com; or
Marcy
Nanus, Telephone: (646) 378-2927, mnanus@troutgroup.com
Posted: December 2009
