QLT announces positive results from the evaluation of Visudyne(R) combination therapy



    VANCOUVER, June 2 /CNW/ - QLT Inc. (NASDAQ:   QLTI; TSX: QLT) today
announced positive twelve-month primary analysis results from the Phase II
RADICAL study (Reduced Fluence Visudyne Anti-VEGF-Dexamethasone In Combination
for AMD Lesions) in patients with wet age-related macular degeneration ("wet
AMD"). The purpose of the study is to determine if Visudyne combined with
Lucentis reduces retreatment rates compared with Lucentis monotherapy, while
maintaining similar vision outcomes and an acceptable safety profile. Three
Visudyne-Lucentis combination therapies were evaluated against Lucentis
monotherapy. The overall results showed that fewer retreatment visits were
required with the combination therapies than with Lucentis monotherapy, and
the differences were statistically significant:

    
    1.  Triple therapy with quarter-fluence Visudyne followed by Lucentis and
        then dexamethsone (P=.04)
    2.  Triple therapy with half-fluence Visudyne followed by Lucentis and
        then dexamethsone (P less than .001)
    3.  Double therapy with half-fluence Visudyne followed by Lucentis
        (P=.04)
    

    While the mean visual acuity (VA) may appear to have improved similarly
across all treatment groups, the confidence intervals were wide. There were no
unexpected safety findings, and adverse event incidence was similar across
treatment groups.
    Of the four treatment groups, the triple therapy half-fluence group
demonstrated the best results, with the fewest retreatment visits and mean VA
improvement most similar to Lucentis monotherapy through 12 months. Patients
in the triple therapy half-fluence group had a mean of 3.0 retreatment visits
compared with 5.4 for patients who received Lucentis monotherapy (P less than
.001). At the month 12 examination, mean VA in the triple therapy half-fluence
group improved 6.8 letters from baseline compared with 6.5 letters in the
Lucentis monotherapy group (P=.94). While all combination groups had
significantly fewer retreatment visits than the Lucentis monotherapy group,
the better results (both in VA change and retreatment visits) in the triple
therapy half-fluence group compared with the other combination groups was a
trend and was not statistically different. Mean retreatment visits and VA
improvement for each treatment group are presented in the table below. All
results presented are based on ITT analyses; per-protocol analyses yielded
similar results. Patients were evaluated for VA and safety, and to assess if
retreatment was needed, at visits every month over 12 months of study
follow-up. Overall, 10 patients discontinued the study by 12 months for
reasons unrelated to Visudyne or Lucentis.

    
               Primary Outcomes from RADICAL Study at 12 Months

    -------------------------------------------------------------------------
                          Triple therapy              Double
                 ------------------------------      therapy       Lucentis
                 Quarter-fluence   Half-fluence   Half-fluence   monotherapy
    -------------------------------------------------------------------------
    ITT              N equals 39    N equals 39    N equals 43   N equals 41

    Mean
     retreatment         4.0        3.0 (P less        4.0
     visits       (P equals .04)     than .001)  (P equals .04)       5.4

    Mean VA
     improvement
     from
     baseline            3.6             6.8           5.0
     (letters)    (P equals .38)  (P equals .94)  (P equals .63)      6.5

    Difference
     from
     Lucentis
     group              -2.9             0.3           -1.6
     (95% CI)        (-9.5, 3.6)    (-6.2, 6.7)     (-8.0, 4.9)         -


    Per-protocol    N equals 37    N equals 34     N equals 33    N equals 32

    Mean
     retreatment         3.9        3.0 (P less         4.3
     visits       (P equals .01)     than .001)  (P equals .047)      5.9

    Mean VA
     improvement
     from
     baseline            3.6             7.6            4.1
     (letters)    (P equals .38)  (P equals .84)  (P equals .46)      6.8
    -------------------------------------------------------------------------
    P values are from comparison with Lucentis monotherapy
    CI: confidence interval
    

    "The ability of Visudyne-Lucentis triple therapy to decrease the number
of retreatment visits for patients while showing vision improvement and an
acceptable safety profile is very encouraging," said Allen C. Ho, M.D., Retina
Diagnostic & Treatment Assoc., LLC, and one of the two lead investigators for
the study. "The RADICAL study has validated our therapeutic approach to wet
AMD," said Henry Hudson, M.D., Retina Centers, PC, the other lead investigator
for the study.
    "Wet AMD is an ocular disease that afflicts people of advanced age, and
doctor visits can be onerous to the patient and the patient's caregiver," said
Bob Butchofsky, Chief Executive Officer of QLT Inc. "We are very pleased that
the RADICAL study demonstrated that Visudyne combination therapy with Lucentis
with or without dexamethasone has the potential to significantly decrease
patient burden by reducing the number of doctor visits. We have showed
combination therapy with Visudyne significantly reduces the need for
retreatment visits through 12 months, which we believe is a great outcome. In
addition to reducing retreatment visits, we also believe that Visudyne
combination therapy is a potential cost effective way to treat patients with
wet AMD."
    The results for secondary VA endpoints in the RADICAL study (percentage
of patients with VA improvement equal to or greater than 15 letters, VA change
equal to or greater than zero letters, and VA loss less than 15 letters) were
consistent with the primary VA endpoint. Ocular adverse events considered
associated with treatment were reported for 33% of patients in the combination
therapy groups, compared with 27% of patients in the Lucentis monotherapy
group. The higher incidence of these events with combination therapy is
primarily due to vision disturbance events (abnormal vision 5 to 10% and
decreased vision 5 to 8%), which are transient and known to be associated with
Visudyne therapy.
    The full results of the 12-month primary analysis of the study are
expected to be presented at a scientific meeting in the fall.

    
    About RADICAL Phase II Study (Reduced Fluence Visudyne
    Anti-VEGF-Dexamethasone In Combination for AMD Lesions)
    

    The RADICAL study is a Phase II, multicenter, randomized, single-masked
study comparing reduced-fluence Visudyne-Lucentis combination therapies (with
or without dexamethasone) to Lucentis monotherapy in 162 subjects with
choroidal neovascularization (CNV) secondary to wet age-related macular
degeneration (wet AMD). Subjects were randomly assigned to one of four
treatment groups: Quarter-fluence Visudyne (180 mW/cm2 for 83 seconds to
deliver 15 J/cm2) followed within two hours by intravitreal Lucentis (0.5 mg)
and then intravitreal dexamethasone (0.5 mg); Half-fluence Visudyne (300mW/cm2
for 83 seconds to deliver 25 J/cm2) followed within two hours by intravitreal
Lucentis (0.5 mg) and then intravitreal dexamethasone (0.5 mg); Half-fluence
Visudyne (300 mW/cm2 for 83 seconds to deliver 25 J/cm2) followed within two
hours by intravitreal Lucentis (0.5 mg); or Lucentis monotherapy (0.5 mg).
Initial treatment in the combination therapy groups was mandatory. The
Lucentis monotherapy group receieved mandatory injections for initial
treatment and the first two months. After mandatory treatment, all treatments
in all groups were PRN. The treatments received in all groups were
experimental: reduced-fluence Visudyne and as-needed Lucentis are not standard
regimens, while dexamethasone and combination therapies for AMD are not
approved for marketing by regulatory agencies. The study duration is 24 months
with a planned primary analysis when all subjects completed 12 months of
follow-up. At baseline, mean best corrected visual acuity letter scores ranged
from 58 to 53 across treatment groups.

    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 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 50J/cm(2)
between 1% and 5% of patients experienced a substantial decrease in vision in
the first 7 days with partial recovery in some patients. Recent studies
suggest that halving the light dose/fluence may lower the incidence of visual
disturbances with similar visual outcomes as the standard light dose which led
to lower light doses being used in this study. After treatment, patients
should avoid direct sunlight for five days to prevent sunburn. People with
porphyria should not be treated with Visudyne.

    About QLT

    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
field of ophthalmology. In addition, we utilize three unique technology
platforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, to
create products such as Visudyne(R) and Eligard(R) and future product
opportunities. For more information, visit our website at www.qltinc.com.

    
    Atrigel is a registered trademark of QLT USA, Inc.
    Lucentis is a registered trademark of Genentech, Inc.
    Visudyne is a registered trademark of Novartis AG.
    Eligard is a registered trademark of Sanofi-Synthelabo Inc.
    QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc.
    

    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: the results of the Radical Study, or other
clinical studies, may not necessarily result in increased usage of Visudyne;
our expectations for timing to receive and release further data from the
RADICAL study; any future expectations concerning the reduced-fluence
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: uncertainties relating to the timing and
results of the clinical development and commercialization of our products and
technologies (including reduced-fluence 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.





For further information:

For further information: QLT Inc.: 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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