Glaukos Corporation announced in a press release the completion of patient enrollment in its pivotal study evaluating the Preserflo MicroShunt in adult patients with primary open-angle glaucoma (POAG) who failed previous medical and surgical treatment.

According to the company, the Preserflo MicroShunt is a novel, ab externo glaucoma drainage device designed to lower intraocular pressure (IOP). Constructed from a proprietary, biocompatible material known as SIBS [poly(styrene-block-isobutylene-block-styrene)], the Preserflo MicroShunt is an 8.5 mm flexible drainage device featuring planar fins designed to facilitate tissue fixation through a minimally-invasive procedure while helping maintain device positioning and minimize leakage. 

The Preserflo MicroShunt prospective, multi-center, single-arm clinical trial enrolled patients who had previously undergone unsuccessful incisional or cilioablative glaucoma surgery and whose IOP remained inadequately controlled with IOP-lowering medications. The study enrolled its target of at least 110 patients across clinical sites in the United States and Canada. The study’s primary effectiveness endpoint is a 20% or greater reduction in mean diurnal IOP from baseline at 12 months postoperatively without an increase in the number of IOP-lowering medication classes from baseline. Glaukos said it intends to use the study results to support a future FDA 510(k) marketing submission for the Preserflo MicroShunt.

According to the press release, Glaukos holds the exclusive rights to develop and commercialize the Preserflo MicroShunt in the United States, Australia, New Zealand, Canada, Brazil, and Mexico under its license agreement with Santen Pharmaceutical Co. The device is currently approved and commercialized in several of these markets, including Canada and Australia. The device received the CE mark in Europe in 2012. GP