Glaukos completed patient enrollment in a U.S. 510(k) pivotal study for the PRESERFLO MicroShunt in advanced primary open-angle glaucoma.
- Results have not been presented; the study will read out following 12-month postoperative follow-up.
- The trial is designed to show the device can lower eye pressure without increasing reliance on glaucoma medications.
- Data are intended to support a future FDA marketing submission, positioning the MicroShunt as an alternative to conventional filtration surgery.
- The device is already sold in several markets including Canada and Australia, providing an early commercial base ahead of a U.S. filing.
GKOS•
