Glaukos Completes Enrollment in US Pivotal Study of Preserflo MicroShunt for POAG

Glaukos Completes Enrollment for Glaucoma Implant Study - Orange County Business Journal

Glaukos Corp. today announced it has completed enrollment for a 510(k) study of an implantable drainage device designed to lower eye pressure in glaucoma patients. The study enrolled 110 adult patients with primary open-angle glaucoma who failed previous medical and surgical treatment. Results from the study will support a future FDA marketing submission. The device, dubbed Preserflo MicroShunt, is currently approved and commercially available i…

Glaukos Completes Enrollment in US Pivotal Study of Preserflo MicroShunt for POAG

Key Takeaways Glaukos has completed enrollment in its US 510(k) pivotal study evaluating the Preserflo MicroShunt in adults with refractory primary open-angle glaucoma The study will assess whether the device achieves a 20% or greater reduction in mean diurnal IOP at 12 months without increasing the number of glaucoma medication classes Positive study results are expected to support a future FDA marketing submission Glaukos has completed patie…

Glaukos completes enrollment with at least 110 glaucoma patients

The primary endpoint is at least 20% mean diurnal IOP reduction at 12 months without more medication classes; results are intended to support a future FDA filing.