VANCOUVER, March 28 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced
today that results from an investigator-sponsored Phase II study, in patients
with subfoveal choroidal neovascularization (CNV) secondary to age-related
macular degeneration (AMD), showed that a combination therapy of verteporfin
(Visudyne(R)) followed by bevacizumab (Avastin(R)) reduced, by half, the
number of treatments required during the first six months to gain similar
visual acuity compared to Avastin monotherapy. In addition, 30% of the
patients treated using the combination therapy required only a single
combination treatment compared to Avastin monotherapy, with which all patients
required additional treatments.
Visudyne therapy is approved for the treatment of age-related macular
degeneration (AMD) in patients with predominantly classic subfoveal choroidal
neovascularization. QLT Inc. is the manufacturer of Visudyne.
Dr. Michael Potter, the investigator-sponsor of the verteporfin and
bevacizumab (VIA) clinical trial, which was supported by QLT, presented
results today at the 31st Annual Macula Society Meeting that is being held
this week in Florida. The objective of the VIA study was to determine whether
Visudyne, at low or very low fluence rates, in combination with Avastin,
reduces the average number of treatments required, compared to Avastin alone.
"We are very pleased with the clinical outcomes of this study. Our goal
was to see if it is possible to minimize the number of treatments while
maintaining or improving visual acuity in patients with CNV secondary to AMD.
At six months, virtually all the patients treated with the Visudyne
combination therapy gained visual acuity with half the number of treatments
required with Avastin monotherapy. These results are encouraging, and more
research continues to be done to evaluate the benefits of combination therapy
in terms of helping patients improve their vision and also reducing the cost
of treatment," said Michael Potter, MD, FRCSC, Associate Professor, Department
of Ophthalmology and Visual Sciences, Vancouver Hospital/University of British
Columbia Eye Care Centre.
VIA Study Design
This study was a single centre, Phase II randomized, controlled,
double-masked clinical trial involving 36 patients who were assigned to one of
three treatment groups
Group 1: Low fluence Visudyne followed by Avastin
Group 2: Very low fluence Visudyne followed by Avastin
Group 3: Avastin alone
Intravitreal bevacizumab was delivered within two hours of PDT at
baseline. Patients returned monthly thereafter for best-corrected ETDRS visual
acuity (VA) testing, optical coherence tomography (OCT), and ocular
examination. Retreatment decisions were based primarily on OCT. PDT was
administered at months 0, 3, 4, 5 or 6, with a minimum 3-month interval
between verteporfin/sham PDT treatments.
VIA Study Results
Thirty-five of 36 enrolled patients completed the 6-month visit. The
average number of Avastin treatments in Group 3 was 5.1, compared to 2.8 in
Group 1 and 2.4 in Group 2. Over 6 months, patients who were treated in the
Group 1 and Group 2 required significantly fewer treatments on average than
those treated in Group 3 (p=0.005 and p(less than)0.001, respectively). Each
group experienced an average improvement in visual acuity at month 6, compared
to baseline (Group 1: 6.3 letters, p(greater than)0.05; Group 2: 14.1 letters,
p=0.003; and Group 3: 10.8 letters, p(less than)0.001, respectively). Both
combination therapy and mono therapy used in the study were well tolerated.
Additional Study Results Reported on Visudyne Combination Therapy
Additional data demonstrating the potential benefits of Visudyne
combination therapy were reported today at the Macula Society conference by:
Dr. William F. Mieler, investigator and Chairman of the Registry Oversight
Board Committee for QLT's two Visudyne registry studies (RVT001 and RVT002);
Dr. Paolo Lanzetta, investigator for a triple therapy clinical study of
ranibizumab, juxtascleral triamcinolone acetonide and Visudyne; and Dr. Albert
Augustin, investigator of a triple therapy clinical study of Visudyne,
dexamethasone and Avastin. Dr. Lanzetta's investigator-sponsored study was
supported by Novartis AG and Dr. Albert Augustin's investigator-sponsored
study was funded by QLT.
The abstracts for the studies can be found in the final conference
program at: http://www.maculasociety.org/annualmeeting/final_program-08.pdf
QLT Inc. is a global biopharmaceutical company dedicated to the
discovery, development and commercialization of innovative therapies. Our
research and development efforts are focused on pharmaceutical products in the
fields of ophthalmology and dermatology. In addition, we utilize three unique
technology platforms, photodynamic therapy, Atrigel(R) and punctal plugs with
drugs, to create products such as Visudyne and Eligard(R) and future product
opportunities. For more information, visit our web site at www.qltinc.com.
Atrigel is a registered trademark of QLT USA, Inc.
Visudyne is a registered trademark of Novartis AG.
Eligard is a registered trademark of Sanofi-aventis.
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."
Certain statements contained in this press release, which are not
historical facts, are "forward-looking statements," as the term is defined in
the Private Securities Litigation Reform Act of 1995 and constitute
"forward-looking information" within the meaning of applicable Canadian
securities laws. Such forward-looking statements are predictions only and are
subject to risks and uncertainties which can cause actual results to differ
materially from those currently anticipated due to a number of factors, which
include, but are not limited to: the completion and results of studies on
combination therapy, the level of physician acceptance of Visudyne in
combination with other agents and the cost associated with such treatments is
uncertain, and other factors as described in detail in QLT's Annual
Information Form and 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.
For further information:
For further information: QLT Inc.: Vancouver, Canada, Therese Hayes,
Telephone: (604) 707-7000, or 1-800-663-5486, Fax: (604)-707-7001