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 patient enrollment in its US 510(k) pivotal clinical study evaluating the Preserflo MicroShunt in adults with primary open-angle glaucoma (POAG) whose disease remains inadequately controlled despite previous medical and surgical treatment.

The milestone advances the company's effort to seek US regulatory clearance for the glaucoma drainage device, which is designed to reduce IOP through a minimally invasive, ab-externo surgical approach.

According to the company, the Preserflo MicroShunt is an 8.5-mm flexible drainage device constructed from SIBS (poly(styrene-block-isobutylene-block-styrene)), a proprietary biocompatible material. The device incorporates planar fins intended to promote tissue fixation, maintain implant positioning, and minimize leakage following implantation.

"The completion of patient enrollment in our US pivotal study represents an important milestone toward potentially bringing the Preserflo MicroShunt to US patients with advanced glaucoma who are at risk for significant vision loss," said Thomas Burns, chairman and chief executive officer of Glaukos.

Mr. Burns added that the company believes the device could address an unmet clinical need by providing glaucoma specialists with an ab-externo surgical alternative to conventional filtration procedures such as trabeculectomy and tube shunt surgery. He also said the company remains focused on expanding its glaucoma portfolio as the study progresses through patient follow-up.

The prospective, multicenter, single-arm trial enrolled at least 110 patients across sites in the United States and Canada. Eligible participants had previously undergone unsuccessful incisional or cilioablative glaucoma surgery and continued to have inadequately controlled IOP despite treatment with IOP-lowering medications.

The study's primary effectiveness endpoint is achieving at least a 20% reduction in mean diurnal IOP from baseline at 12 months after surgery without an increase in the number of IOP-lowering medication classes compared with baseline. Glaukos plans to use the study findings to support a future FDA marketing submission for the device.

Glaukos holds exclusive rights to develop and commercialize the Preserflo MicroShunt in the United States, Australia, New Zealand, Canada, Brazil, and Mexico under a licensing agreement with Santen.

The device is already approved and commercially available in several international markets, including Canada and Australia, where the company said surgeon adoption continues to increase alongside growing real-world evidence supporting its safety and effectiveness.