Mati Therapeutics Inc. Announces Initiation of Phase II Study to Compare Latanoprost Punctal Plug Delivery System (L-PPDS) to Timolol Eye Drops
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.