QLT initiates phase II study of punctal plug drug delivery system for glaucoma & ocular hypertension

01-Apr-2008

QLT Inc. announced 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.

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