Glaukos Trial Nears FDA Goal for Glaucoma Device

Glaukos has concluded patient enrollment for its pivotal US 510(k) trial assessing the Preserflo MicroShunt drainage device. This trial specifically targets adult patients with primary open-angle glaucoma whose condition has not adequately responded to previous medical or surgical interventions. The Preserflo MicroShunt, made from the biocompatible material SIBS, is an ab-externo device designed to reduce intraocular pressure through a minimally invasive procedure. It features an 8.5mm flexible design.

The prospective, multi-center, single-arm study enrolled at least 110 patients across sites in the US and Canada. Participants had previously undergone unsuccessful glaucoma surgeries or treatments and had intraocular pressure not controlled by medication. The primary effectiveness endpoint measured is a 20% or greater reduction in mean diurnal intraocular pressure at 12 months post-surgery, without an increase in medication classes.

This enrollment milestone is crucial for Glaukos' strategy to support a future submission to the US Food and Drug Administration (FDA) for marketing clearance. The company holds exclusive rights for the Preserflo MicroShunt in several international markets, including Australia and Canada, where it is already commercially available. The successful completion of enrollment brings the device closer to potential availability for US patients facing advanced glaucoma and vision loss risks.