VANCOUVER, March 31 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI; TSX:QLT) announced today the initiation of patient recruitment into its "CORE"study, a phase II trial being conducted by QLT's wholly-owned subsidiary, QLTPlug Delivery, Inc. ("QPD"), to evaluate the preliminary efficacy and safetyof its latanoprost punctal plug delivery system for the treatment of glaucomaand ocular hypertension. The punctal plug delivery system is a non-invasivedrug delivery system that is being developed with a goal of being capable ofdelivering a variety of drugs to the eye over time through sustained releaseto the tear film.
"I believe that a punctal plug drug delivery system could be a catalystfor a paradigm shift in how glaucoma is treated and this clinical study is acritical first step in evaluating a component of this system, and it'spotential to help patients manage their disease. If successful, these plugscould eliminate the patient's dosing dependency and possibly provideconsistent 24-hour control for intraocular pressure (IOP). Our goal in 2008 isto deliver drug in a punctal plug delivery system to glaucoma patients forperiods of approximately 90 days, with the aim of leading to a therapeuticdrop in IOP," said Bob Butchofsky, President and Chief Executive Officer ofQLT.
This study is a phase II, randomized, masked, parallel-group study ofsafety and preliminary efficacy of a punctal plug drug delivery systeminvolving up to 60 patients with primary open-angle glaucoma or ocularhypertension. The punctal plug drug delivery system in this study consists ofthree 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 anactive ingredient that has been approved by the Food and Drug Administrationfor reducing elevated intraocular pressure in patients with open-angleglaucoma or ocular hypertension. It is the most-prescribed glaucoma medicinein 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 andsafety of the punctal plug drug delivery system, and to determine anappropriate concentration(s) of drug to advance into late-stage development.Enrolled subjects will be randomized in an equal ratio to receive one of threeconcentrations (low, medium, high) and will be followed for 16 weeks.
Preliminary efficacy will be evaluated by the proportion of subjects whohave not lost efficacy, defined as an IOP increase to within 2 mmHg belowbaseline IOP while wearing a punctal plug with drug that has been continuouslyin place since Day 0, and with IOP variables including Goldmann IOPmeasurements, IOP change from baseline, and percentage IOP change frombaseline.
Glaucoma affects approximately 65 million patients around the world todayand is the second leading cause of blindness in the western world, accordingto the Glaucoma Research Foundation, and WHO. Further, over 50% of glaucomapatients are noncompliant with their eye drop regimen within six months,meaning patients don't refill their prescriptions beyond six months (AmericanJournal of Ophthalmology. v.140 #4 Oct. 2005) and still, the U.S. market aloneis currently a $1.7 billion opportunity. A chronic life-long disease, glaucomais 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 anddevelopment efforts are focused on pharmaceutical products in the fields ofophthalmology and dermatology. In addition, we utilize three unique technologyplatforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, tocreate products such as