Glaukos Announces Completion of Patient Enrollment in 510(k) Pivotal Study for PRESERFLO™ MicroShunt
Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, today announced the completion of patient enrollment in its U.S. 510(k) pivotal study evaluating the PRESERFLO™ MicroShunt in adult patients with primary open-angle glaucoma (POAG) who failed previous medical and surgical treatment.
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 completion of patient enrollment in our U.S. pivotal study represents an important milestone toward potentially bringing the PRESERFLO MicroShunt to U.S. patients with advanced glaucoma who are at risk for significant vision loss,” said Thomas Burns, Glaukos chairman and chief executive officer. “We believe the PRESERFLO MicroShunt has the potential to address an important unmet clinical need by providing glaucoma specialists with an elegant, ab-externo surgical alternative to conventional filtration procedures such as trabeculectomy and tube shunt surgery. As we advance into the next phase of this clinical program through patient follow-up, we remain committed to expanding our comprehensive, best-in-class portfolio of novel glaucoma therapies designed to address the evolving needs of patients and physicians across the full continuum of glaucoma care.”
