QLT INC.
- First reported demonstration of a clinically significant, prolonged (4 weeks) reduction in intraocular
pressure (IOP) in glaucoma with an extraocular, minimally-invasive sustained release ophthalmic
drug delivery system
- After 4 weeks of L-PPDS treatment, the mean IOP reduction from baseline was -5.7 mmHg
- 60% of subjects at 4 weeks showed an IOP reduction of 5 mmHg or greater
- Retention of QLT’s proprietary punctal plug placed in the lower punctum was 95% at 4 weeks
- Clinical results to be discussed during the Company’s conference call today at 8:30 a.m. ET
For Immediate Release August 29, 2011
VANCOUVER, CANADA—QLT Inc. (NASDAQ: QLTI; TSX: QLT) today announced results of its
Phase II clinical study on the efficacy and safety of the Latanoprost Punctal Plug Delivery System (LPPDS)
in subjects with ocular hypertension (OH) and open-angle glaucoma (OAG).
The Phase II trial featured simultaneous placement of punctal plugs in both the upper and lower puncta
for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily
administered Xalatan® eye drops. The Company’s overall drug development objective was a mean
reduction in IOP of 5 mmHg or greater. The primary endpoint in this Phase II study was the mean change
in IOP from baseline (measured as mmHg) at 2 weeks. Secondary endpoints were the mean change in
IOP from baseline at 4 weeks and mean percentage change in IOP from baseline at 2 weeks and 4 weeks.
A total of 95 ITT (Intent to Treat) subjects were included in the L-PPDS treatments in this study. The
mean IOP at baseline was 25.8 mmHg for this group.
After 2 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of
-6.2 mmHg (95% C.I. -6.8, -5.6). At the end of 2 weeks, 73% of subjects showed an IOP reduction vs.
baseline of 5 mmHg or greater and 51% of subjects showed a reduction of 6 mmHg or greater. The mean
percentage change in IOP from baseline at 2 weeks was -24.3%, which was statistically significant (95%
C.I. -26.7, -21.9).
After 4 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of
-5.7 mmHg (95% C.I. -6.5, -4.9). At the end of 4 weeks, 60% of subjects showed an IOP reduction vs.
baseline of 5 mmHg or greater and 47% of subjects showed a reduction of 6 mmHg or greater. The mean
percentage change in IOP from baseline at 4 weeks was also statistically significant at 22.3% (95% C.I. -
25.4, -19.2). Results reported in earlier Phase II L-PPDS studies using different L-PPDS plug designs and
doses did not achieve these levels of IOP reduction over a 4 week treatment period.
“Most if not all glaucoma specialists would agree that eye pressure lowering should be taken out of the
patients’ hands and left in the hands of the physician,” said Alan L. Robin, MD, Associate Professor
Ophthalmology and International Health at Johns Hopkins University and Clinical Professor of
Ophthalmology, University of Maryland. “The results of the QLT study find the L-PPDS may offer a
breakthrough in the way glaucoma medication can be delivered. The results suggest that the L-PPDS may
have the ability to deliver long-lasting clinically significant eye pressure lowering that is relatively welltolerated
by patients so that they do not have to worry about eye drop instillation. Adherence no longer
becomes a factor in preventing the development of needless blindness. Additionally, the procedure
appears to be relatively safe, minimally-invasive and simple to perform. With further development
success, this delivery system could potentially revolutionize our therapy of glaucoma.”
Table 1 - Glau 11 Phase II data *
Mean Change in IOP from Baseline
(95% C.I.)
Mean % Change in IOP
from Baseline (95% C.I.)
2 weeks
(n=70) ** -6.2 (-6.8, -5.6) -24.3% (-26.7%, -21.9%)
4 weeks
(n=53) ** -5.7 (-6.5,-4.9) -22.3% (-25.4%, -19.2%)
* Study sample size of 50 subjects was planned to provide a statistically reliable estimate of the mean IOP
change from baseline with a 95% Confidence Interval
** Number of subjects who met ITT (Intent to Treat) and plug retention criteria (both upper and lower
plug retained in at least one eye)
“We are very excited to see clinically meaningful data showing that a higher dose of latanoprost
administered through a double plug approach can successfully decrease IOP by more than 5 mmHg,” said
Bob Butchofsky, President and CEO of QLT Inc. “As a result, we plan to move forward with another
Phase II trial in glaucoma and broaden this delivery platform by accelerating plans for a second molecule
in 2012.”
The trial utilized the Company’s newest version of its later stage proprietary punctal plug in the lower
punctum and an early stage prototype upper punctal plug based on a modified commercially available
plug, providing a combined latanoprost amount of 141 μg. The proprietary lower punctal plugs were
retained in 95% of subjects at 4 weeks. The modified commercially available upper punctal plugs were
retained in 45% of subjects at 4 weeks. Using a 4 week benchmark, the subject retention rate for the
proprietary lower punctal plug designs utilized in previous studies was 49% - 90%.
The L-PPDS was well tolerated over the testing period with adverse events (AEs) similar to those
reported for commercial punctal plugs. The majority of AEs were ocular in nature, with tearing reported
as the most frequent. No associated AEs were serious. As assessed by subjective scoring by study
subjects, tearing was rated predominantly for L-PPDS treated eyes at week 4 as occasional - 22%, mild -
31%, or moderate - 32%. Few subjects experienced any discomfort related to the punctal plugs with most
patients having either no awareness or mild awareness of the punctal plugs by week 4 (87% of eyes for LPPDS
subjects). A total of 42 subjects were not included in the ITT analysis at week 4, with 34 of these
due to losses of the early stage prototype upper plug. During the study, 5 subjects discontinued due to
AEs, and 3 subjects discontinued for other reasons. All subjects were included in the safety analysis.
About the L-PPDS Phase II Study
This completed Phase II multicenter study was conducted to evaluate the safety and efficacy of the LPPDS
utilizing simultaneous placement of punctal plugs in the upper and lower puncta containing a
combined total of 141 μg of latanoprost, a prostaglandin analogue, in subjects with ocular hypertension
(OH) or open-angle glaucoma (OAG) over a 4 week period. The original study design randomized
subjects into one of two treatment groups: (i) placebo/L-PPDS (4 weeks placebo + 4 weeks L-PPDS), and
(ii) sham/Xalatan® (4 weeks sham + 4 weeks Xalatan® drops). In April 2011, the trial design was
amended to remove the sham/Xalatan® arm and to remove an initial 4 week placebo plug period from the
study. These changes simplified the trial design and provided earlier access to active treatment in the
study, which reduced the rate of patient discontinuation in the trial. The Principal Investigator for the
study was Dr. Robert Williams, formerly of the Taustine Eye Center in Louisville, KY.
Updated R&D Guidance
Research and Development (R&D) expense in the first half of 2011 was $21.1 million, and the Company
previously provided guidance for R&D expense of approximately $10 million to $12 million for the third
quarter of 2011. With the results of the Phase II L-PPDS study in hand, the Company is now providing
R&D guidance for full year 2011 of $44 million to $46 million. Major R&D initiatives for the remainder
of the year relating to the QLT091001 Phase 1b trial in patients with Leber Congenital Amaurosis (LCA)
and Retinitis Pigmentosa (RP) include: (i) ongoing follow-up of LCA patients, (ii) initial re-treatment of
LCA patients treated in the trial, (iii) completion of enrollment in the RP cohort, and (iv) ongoing
formulation and development work. For the punctal plug drug delivery program, near term development
goals include further evaluation of the single versus double plug approaches and enabling a longer
duration of sustained release. Major R&D plans for this program include commencing another Phase II
trial in glaucoma, device work in particular for upper puncta placement, and ongoing formulation and
development work in particular for new product candidates.
Conference Call Information
QLT Inc. will hold an investor conference call today to discuss the announcement 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 15 minutes prior to the
call on QLT’s web site at www.qltinc.com. 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 8762,
followed by the “#” sign.
About QLT
QLT is an ocular-focused company dedicated to the development and commercialization of innovative
ocular products that address the unmet medical needs of patients and clinicians worldwide. We are
focused on developing our synthetic retinoid program for the treatment of certain inherited retinal
diseases, developing drugs to be delivered in our proprietary punctal plug delivery system, as well as U.S.
marketing of the commercial product Visudyne® (which we co-developed with Novartis) for the treatment
of wet age-related macular degeneration. QLT’s head office is based in Vancouver, Canada and the
Company is publicly traded on NASDAQ (symbol: QLTI) and the Toronto Stock Exchange (symbol:
QLT). For more information about the Company’s products and developments, please visit our website at
www.qltinc.com.
QLT Inc. Investor Relations Contact:
David Climie
VP, Investor Relations
Telephone: 604-707-7573
[email protected]
QLT Inc. Media Contact:
Karen Peterson
Communications Specialist
Telephone: 604-707-7000 or 1-800-663-5486
[email protected]
The Trout Group Investor Relations Contact:
Christine Yang (NY)
Telephone: 646-378-2929
[email protected]
or
Tricia Swanson (Boston)
Telephone: 646-378-2953
[email protected]
Visudyne® is a registered trademark of Novartis AG.
Eligard® is a registered trademark of Sanofi S.A.
Xalatan® is a registered trademark of Pfizer Health AB.
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.”