QLT announces encouraging Phase II data from core study of Punctal Plug Drug Delivery System



    
    Sustained release treatment leads to reduction in IOP of 20% from
    baseline at 12 weeks
    

    VANCOUVER, Oct. 28 /CNW/ - QLT Inc. (NASDAQ:   QLTI; TSX: QLT) ("QLT" or
the "Company") today announced data from its CORE study, a Phase II trial
being conducted by QLT's wholly-owned subsidiary, QLT Plug Delivery, Inc.
(QPD), to evaluate the safety and efficacy of its Latanoprost Punctal Plug
Delivery System (L-PPDS) for the treatment of open angle glaucoma (OAG) and
ocular hypertension (OH). Sixty-one patients were enrolled in the study and 23
patients discontinued before the Week-12 visit due to either loss of
efficacy/inadequate IOP control (19 patients) or loss of L-PPDS in both eyes
(four patients). The mean change in intraocular pressure (IOP) from baseline
at 12 weeks among patients who completed the study was -5.4 mmHg, -4.8 mmHg
and -4.9 mmHg for the low, medium, and high concentrations of latanoprost
respectively. This represents a clinically meaningful reduction of 20% from
baseline at the 12-week time point in those patients. The L-PPDS were well
tolerated during the course of treatment.
    "We are pleased to report the results from our proof-of-concept Phase II
CORE study, which showed a reduction in IOP that is within the acceptable
range for physicians treating patients with glaucoma," said Bob Butchofsky,
President and Chief Executive Officer of QLT. "This data confirms the
viability of the approach we have pioneered, of employing punctal plugs as a
non-invasive method of delivering already approved drugs to the eye. We plan
to continue to investigate additional doses to see if efficacy may be further
enhanced."
    "The Latanoprost Punctal Plug Delivery System represents one of the most
exciting exploratory programs addressing the unmet medical need of poor
compliance and adherence patterns to treatment regimens seen in glaucoma and
ocular hypertensive patients," said Lou Cantor, MD, Director, Glaucoma
Service, Indiana University School of Medicine, Department of Ophthalmology
and a QLT Clinical Advisory Board member. "Non-compliance by glaucoma and OH
patients reduces treatment benefits and is associated with a poorer prognosis.
The CORE data reaffirms that QLT's punctal plugs could potentially address
some of the most frequent barriers to compliance and could represent a huge
shift in the way that glaucoma will be treated in the future."

    The CORE Phase II Study

    This CORE study is a Phase II, randomized, double-masked, parallel-group,
multicenter study conducted to investigate the safety and preliminary efficacy
of three different concentrations of latanoprost, a prostaglandin analogue
with a punctal plug delivery system in patients with open angle glaucoma or
ocular hypertension over a 12-week period. Sixty-one patients diagnosed with
OAG/OH with a mean age of 65 years (40 to 87 years) were randomly assigned to
receive one of three doses (3.5, 14, and 21 (micro)g) of the latanoprost
punctal plug delivery system. The mean baseline IOP was 24.4 +/- 2.1 mmHg for
the patient population. There was no dose response relationship observed
within the dose range studied in CORE.

    
    Summary (mean +/- SD) of the IOP change from baseline (mmHg) for the
    three doses over time:
    -------------------------------------------------------------------------
                          3.5 (micro)g       14 (micro)g       21 (micro)g
    -------------------------------------------------------------------------
    Week 4               N=20   N=19   N=21
                          -3.9 +/- 2.7      -3.4 +/- 3.1      -3.2 +/- 3.3

    -------------------------------------------------------------------------
    Week 8               N=17   N=15   N=15
                          -3.6 +/- 2.4      -4.2 +/- 3.7      -4.4 +/- 2.4

    -------------------------------------------------------------------------
    Week 12              N=13   N=12   N=13
                          -5.4 +/- 2.7      -4.8 +/- 3.2      -4.9 +/- 2.1

    -------------------------------------------------------------------------
    Note: Mean IOP changes from baseline in the table are all statistically
    significant at P(less than)0.001
    

    The L-PPDS was well-tolerated over the testing period. The overall
adverse events ranged from 1.6% to 14.8% and were not dose dependant. The most
common adverse events were increased lacrimation (tear production) and ocular
discomfort (14.8% and 9.8%, respectively) which were mild and transient in
nature and were most likely resolved during the adaptation period to punctal
plug wear. Ocular hyperemia and punctate keratitis rates were 1.6% each. At
Week 12, patient-reported comfort and tearing scores were favorable: 89% of
patients rated L-PPDS comfort as 'no awareness' and 8% 'mild awareness,' while
tearing was rated as 'none' (78%), 'occasional' (14%), or 'mild' (5%). The
remaining 3% of patients did not have a comfort and tearing assessment at Week
12. In the CORE study, the punctal plug retention rate utilizing a
commercially available conventional punctal plug was 76% despite having
patients pre-screened for plug retention for eligibility into the trial.
    QLT currently plans to initiate a second Phase II trial in patients with
OAG or OH over a 12-week period to investigate the efficacy of a proprietary
punctal plug prototype in conjunction with a dose of latanoprost that is at
least 10-fold higher than the lowest dose used in the CORE study.
    Although there was no dose response observed in CORE, the doses tested
were closely grouped (less than 1 log unit apart) and represent the low end of
potential doses for the product. The study investigated sustained-release
doses that were much lower than those present in latanoprost eye drops used
over a similar time period.

    About Latanoprost Punctal Plug Delivery System (L-PPDS)

    The L-PPDS is a novel, sustained and controlled release drug delivery
system that utilizes the puncta to house a drug-eluting device. The L-PPDS is
currently being investigated as a treatment for OAG and OH patients to
particularly address patient non-compliance issues. The punctal plug delivery
system is a non-invasive drug delivery system that is being developed with a
goal of enabling delivery of a variety of drugs to the eye over time through
sustained release to the tear film.

    About Prostaglandins

    Prostaglandins represent the largest segment of the U.S. glaucoma market.
Latanoprost is an active ingredient that has been approved by the Food and
Drug Administration for reducing elevated intraocular pressure in patients
with open-angle glaucoma or ocular hypertension. It is the most-prescribed
glaucoma medicine in the world and in 2007 had franchise sales of $1.7 billion
(IMS Health).

    Conference call information

    QLT Inc. will hold an investor conference call to discuss third quarter
2008 results and the CORE L-PPDS study results today, Tuesday, October 28,
2008 at 8:30 a.m. ET (5:30 a.m. PT). The call with slides will be broadcast
live via the Internet at www.qltinc.com. To participate on the call, please
dial 1-800-319-4610 (North America) or 604-638-5340 (International) before
8:30 a.m. ET. For those dialing in to the call, the presentation slides will
be available on QLT's web site at
http://www.qltinc.com/Qltinc/main/mainpages.cfm?InternetPageID=366. A replay
of the call will be available via the Internet and also via telephone at
1-800-319-6413 (North America) or 604-638-9010 (International), access code
7157, followed by the number sign.

    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.

    
    QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc.
    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 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 expectations for timing to receive data
from our CORE study; further investigations that we intend to conduct in our
CORE study; our future expectations about our punctal plug delivery system;
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 Company's future operating results are uncertain
and likely to fluctuate; uncertainties relating to the timing and results of
the clinical development and commercialization of our products and
technologies (including Visudyne 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 Strickler, Telephone: (646) 378-2927

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