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Glaukos Announces Completion of Patient Enrollment in 510(k) Pivotal Study for PRESERFLO™ MicroShunt

GKOS
  • Glaukos Corporation completed patient enrollment in its U.S. 510(k) pivotal study for the PRESERFLO MicroShunt in adult patients with primary open-angle glaucoma who failed prior medical & surgical treatment.
  • The PRESERFLO MicroShunt is an 8.5 mm flexible drainage device made of proprietary SIBS material designed to lower intraocular pressure via a minimally invasive ab-externo procedure.
  • The multi-center, single-arm clinical trial enrolled at least 110 patients across U.S. & Canadian sites, meeting its target for subjects with uncontrolled intraocular pressure despite previous incisional or cilioablative surgeries.
  • The study's primary effectiveness endpoint requires a 20% or greater reduction in mean diurnal intraocular pressure at 12 months without increasing the number of medication classes.
  • Glaukos intends to use the trial results to support a future FDA marketing submission for the PRESERFLO MicroShunt.
  • Glaukos holds exclusive U.S., Australian, New Zealand, Canadian, Brazilian, & Mexican rights to the device under a license with Santen Pharmaceutical Co., Ltd.
  • The device is already approved & commercialized in Canada & Australia, where surgeon adoption is growing alongside favorable real-world evidence.
  • Glaukos continues to advance a pipeline of novel therapies including the recently launched iDose TR intracameral drug delivery system & a corneal cross-linking therapy for keratoconus.