AUSTIN, Texas, Oct. 28, 2013 (GLOBE NEWSWIRE) -- Mati Therapeutics Inc. ("Mati") today announced the initiation of a Phase II trial of its L-PPDS drug delivery system in patients with ocular hypertension or primary open angle glaucoma. The study will be a U.S. based, randomized, multi-center trial of approximately 100 patients treated with L-PPDS or timolol eye drops for up to 14 weeks. The primary end point for the comparative treatments will be change from baseline in intraocular pressure (IOP). A number of secondary endpoints will also be evaluated.
This trial is the first trial to compare L-PPDS to timolol eye drop therapy. Results from this trial are expected by the third quarter of 2014 and will be used to determine the appropriate study design for a potential Phase III pivotal trial of L-PPDS. To date, more than 570 subjects have been treated in various L-PPDS dose-ranging Phase II studies. The Phase II study will evaluate a 95ug formulation of latanoprost in Mati's proprietary punctal plug. In past studies, 160 subjects were treated with this dose of latanoprost administered through L-PPDS. Across these subjects, L-PPDS was shown to reduce average IOP by approximately 20% at the Week 12 time point.
Mati's objective with L-PPDS is to develop a minimally invasive, sustained drug delivery approach to treat patients with glaucoma or ocular hypertension. The Mati drug delivery platform aims to address patient non-compliance with eye drop medication - a long standing problem in ophthalmology - by replacing the need for every day administration by the patient with a sustained delivery system.
About Mati Therapeutics Inc. - Mati was formed in December 2012. In April 2013, Mati acquired the intellectual property and other assets comprising the punctal plug delivery system from QLT Inc. The punctal plug delivery system combines a drug core with an anchoring device. The anchoring device is called a punctal plug, which is commonly used in ophthalmology to treat dry eye syndrome. Punctal plugs are placed in the tear duct (punctum) of the eye to prevent the drainage of tears from the surface of the eye. A drug-eluting core is inserted into the punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. L-PPDS is Mati's first product candidate. Mati's wholly-owned R&D subsidiary, Mati Therapeutics (Canada) Inc., is based in Richmond, British Columbia.