Glaukos Completes Enrollment in Pivotal Study for Glaucoma Drainage Device — Glaukos Corporation

Event summary

Glaukos completed patient enrollment in its U.S. pivotal study for the PRESERFLO MicroShunt, targeting at least 110 patients with primary open-angle glaucoma.
The study evaluates the device's effectiveness in reducing intraocular pressure (IOP) by 20% or more at 12 months postoperatively without increasing medication classes.
Glaukos aims to use the study results to support a future FDA marketing submission for the PRESERFLO MicroShunt.
The device is already approved and commercialized in Canada and Australia, with growing surgeon adoption.

The big picture

Glaukos' completion of patient enrollment in the pivotal study for the PRESERFLO MicroShunt marks a critical step in expanding its portfolio of glaucoma therapies. The device's design, featuring a minimally-invasive procedure and proprietary biocompatible material, aims to address an unmet need for patients with advanced glaucoma. This development comes as Glaukos continues to innovate in the ophthalmic space, following the launch of iDose TR in 2024 and its focus on dropless platform technologies.

What we're watching

Regulatory Pathway: The pace at which Glaukos can secure FDA approval for the PRESERFLO MicroShunt, given the completion of patient enrollment.
Market Expansion: Whether Glaukos can replicate the device's success in the U.S. market, following its approval and growing adoption in Canada and Australia.
Competitive Dynamics: How the PRESERFLO MicroShunt will position against existing glaucoma treatments like trabeculectomy and tube shunt surgery.