Glaukos has concluded patient enrolment in its US 510(k) pivotal trial assessing the Preserflo MicroShunt drainage device in adults with primary open-angle glaucoma.
The study targets patients whose condition has not responded to previous medical or surgical treatment.
The Preserflo MicroShunt can reduce intraoccular pressure and features an 8.5mm flexible design made from SIBS [poly(styrene-block-isobutylene-block-styrene)], a biocompatible material.
This ab-externo device aims to reduce intraocular pressure through a minimally invasive procedure.
The pivotal prospective, multi-centre, single-arm study is taking place at sites in the US and Canada.
It enrolled patients who have previously undergone unsuccessful incisional or cilioablative glaucoma surgeries and whose intraocular pressure has not been adequately controlled despite medication.
The enrolment target of at least 110 patients was reached. The main effectiveness endpoint is a reduction of 20% or more in mean diurnal intraocular pressure from baseline at 12 months following surgery, with no increase in the number of pressure-lowering medication classes.
Glaukos chairman and CEO Thomas Burns said: “The completion of patient enrolment in our US pivotal study represents an important milestone toward potentially bringing the Preserflo MicroShunt to US patients with advanced glaucoma who are at risk for significant vision loss.”
Glaukos plans to use the trial data to support a future submission to the US Food and Drug Administration for marketing clearance of the device.
The company holds exclusive development and commercialisation rights for Preserflo MicroShunt in Australia, Brazil, Canada, Mexico, New Zealand, and the US via a licence agreement with Santen Pharmaceutical.
The device has obtained approval and is commercially available in markets, including Australia and Canada.
