Aliso Viejo, California, July 27, 2026
Glaukos Corporation announced the completion of patient enrollment in its U.S. 510(k) pivotal clinical study evaluating the PRESERFLO™ MicroShunt for adults with primary open-angle glaucoma (POAG) who have experienced failure with previous medical and surgical treatments. The milestone advances the company’s regulatory strategy toward a future FDA marketing submission for the minimally invasive glaucoma drainage device. Designed to reduce intraocular pressure (IOP) through a minimally invasive surgical procedure, the PRESERFLO MicroShunt aims to provide an alternative treatment option for patients at high risk of progressive vision loss due to advanced glaucoma.
Pivotal Trial Advances Toward FDA Marketing Submission
The prospective, multicenter, single-arm 510(k) pivotal trial successfully enrolled its target of at least 110 patients across clinical sites in the United States and Canada. The study includes adult patients with primary open-angle glaucoma whose previous incisional or cilioablative glaucoma surgeries failed to adequately control intraocular pressure despite continued use of IOP-lowering medications. The primary effectiveness endpoint will evaluate whether patients achieve at least a 20% reduction in mean diurnal intraocular pressure from baseline after 12 months, without increasing the number of glaucoma medication classes. Glaukos plans to use the study results to support a future FDA marketing application for the device.
PRESERFLO MicroShunt Designed for Advanced Glaucoma Management
The PRESERFLO™ MicroShunt is an 8.5 mm flexible glaucoma drainage implant constructed from the proprietary SIBS (poly(styrene-block-isobutylene-block-styrene)) biocompatible material. Designed for ab-externo implantation, the device lowers intraocular pressure by facilitating controlled drainage of aqueous humor through a minimally invasive procedure. Its integrated planar fin design helps maintain device stability, supports tissue fixation, and minimizes leakage following implantation. According to Glaukos, the MicroShunt has the potential to provide glaucoma specialists with an effective surgical alternative to conventional filtration procedures such as trabeculectomy and tube shunt surgery, particularly for patients with advanced disease who require additional treatment options.
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Global Commercial Experience Supports Continued Development
Glaukos holds exclusive commercialization rights for the PRESERFLO MicroShunt in the United States, Canada, Australia, New Zealand, Brazil, and Mexico under its licensing agreement with Santen Pharmaceutical Co., Ltd. The device has already received regulatory approval and is commercially available in several international markets, including Canada and Australia, where physician adoption continues to expand alongside growing real-world evidence supporting its safety and clinical effectiveness. Completion of patient enrollment marks an important step toward potentially expanding access to the innovative glaucoma therapy in the United States while strengthening Glaukos’ comprehensive portfolio of ophthalmic medical technologies aimed at improving long-term outcomes for patients with chronic eye diseases.
Source: Glaukos press release
