QLT Inc. Initiates Phase II Study of Punctal Plug Drug Delivery System for Glaucoma & Ocular Hypertension
Published: Mar 31, 2008
VANCOUVER, March 31 /PRNewswire-FirstCall/ - QLT Inc. announced today the initiation of patient recruitment into its "CORE" study, a phase II trial being conducted by QLT's wholly-owned subsidiary, QLT Plug Delivery, Inc. ("QPD"), to evaluate the preliminary efficacy and safety of its latanoprost punctal plug delivery system for the treatment of glaucoma and ocular hypertension. The punctal plug delivery system is a non-invasive drug delivery system that is being developed with a goal of being capable of delivering a variety of drugs to the eye over time through sustained release to the tear film.
"I believe that a punctal plug drug delivery system could be a catalyst for a paradigm shift in how glaucoma is treated and this clinical study is a critical first step in evaluating a component of this system, and it's potential to help patients manage their disease. If successful, these plugs could eliminate the patient's dosing dependency and possibly provide consistent 24-hour control for intraocular pressure (IOP). Our goal in 2008 is to deliver drug in a punctal plug delivery system to glaucoma patients for periods of approximately 90 days, with the aim of leading to a therapeutic drop in IOP," said Bob Butchofsky, President and Chief Executive Officer of QLT.
This study is a phase II, randomized, masked, parallel-group study of safety and preliminary efficacy of a punctal plug drug delivery system involving up to 60 patients with primary open-angle glaucoma or ocular hypertension. The punctal plug drug delivery system in this study consists of three different concentrations of latanoprost, a prostaglandin analogue.
Prostaglandins represent the largest segment of the U.S. glaucoma market, accounting for approximately $700 million in sales in 2005. 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 2006 had franchise sales of $1.7 billion (IMS Health).
CORE Study Objectives
The study objectives are to investigate the preliminary efficacy and safety of the punctal plug drug delivery system, and to determine an appropriate concentration(s) of drug to advance into late-stage development. Enrolled subjects will be randomized in an equal ratio to receive one of three concentrations (low, medium, high) and will be followed for 16 weeks.
Preliminary efficacy will be evaluated by the proportion of subjects who have not lost efficacy, defined as an IOP increase to within 2 mmHg below baseline IOP while wearing a punctal plug with drug that has been continuously in place since Day 0, and with IOP variables including Goldmann IOP measurements, IOP change from baseline, and percentage IOP change from baseline.
Glaucoma affects approximately 65 million patients around the world today and is the second leading cause of blindness in the western world, according to the Glaucoma Research Foundation, and WHO. Further, over 50% of glaucoma patients are noncompliant with their eye drop regimen within six months, meaning patients don't refill their prescriptions beyond six months (American Journal of Ophthalmology. v.140 #4 Oct. 2005) and still, the U.S. market alone is currently a $1.7 billion opportunity. A chronic life-long disease, glaucoma is a major health problem, with people needlessly losing vision as a result.
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.
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 that 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. Forward-looking statements include, but are not limited to: our beliefs regarding the potential benefits, targets, market opportunity and commercial success of our punctal plug drug delivery system; our expectations regarding our clinical development plans and strategy for the technology and timelines associated with these; and statements which contain language such as "expects," "will," "plans," "estimates," "intends," "believes" and similar expressions that do not relate to historical matters. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from the results expressed or implied by 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: risks and uncertainties associated with the timing, expense and outcome of research and development programs and commercialization of products (including the difficulty of predicting the timing and outcome of the punctal plug development efforts, clinical testing and regulatory approvals or actions); 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 other factors as 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.
CONTACT: QLT Inc.: Vancouver, Canada, Therese Hayes, Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604) 707-7001
CONTACT: QLT Inc.: Vancouver, Canada, Therese Hayes, Telephone: (604)
707-7000 or 1-800-663-5486, Fax: (604) 707-7001