The Therapeutic Goods Administration (TGA) of Australia has approved Glaukos’ PRESERFLO MicroShunt for lowering intraocular pressure (IOP) in eyes of people with primary open-angle glaucoma.
The device is indicated for patients whose IOP is not controlled using maximum tolerated medical treatments and/or when glaucoma progression requires a surgical procedure.
An ab-externo system, PRESERFLO MicroShunt aids in draining eye fluid and lowering IOP in primary open-angle glaucoma patients.
Lowering IOP is an efficient way to stop glaucoma progression and loss of vision, the company said.
This drainage system, made from a biocompatible material called poly(styrene-block-isobutylene-block-styrene), SIBS, is a flexible, 8.5mm-long tube with planar fins.
The fins enable fixing of the device in the tissue via a micro-incision and stop leakage or migration.
Glaukos president and CEO Thomas Burns said: “We are delighted to receive regulatory approval from Australia’s TGA for the MicroShunt, marking a notable milestone in advancing our goal to bring this important late-stage glaucoma technology to ophthalmic surgeons and patients.
“We believe there is a strong appetite within the global ophthalmic community for the MicroShunt as a more elegant, ab-externo alternative to conventional filtration surgeries for late-stage glaucoma management.”
Glaukos intends to start the initial commercial launch of the new device in Australia later this year. A full launch is expected next year after establishing a formal reimbursement.
As per a licencing agreement with Santen Pharmaceutical, Glaukos holds exclusive marketing and development rights for the device in Australia.
Glaukos also holds exclusive marketing rights and regulates all development works, including clinical development and regulatory activities for PRESERFLO in the US, Canada, New Zealand, Mexico, Brazil and other countries in Latin America.
An ophthalmic medical technology and pharmaceutical firm, Glaukos focuses on developing new treatments for glaucoma, corneal disorders and retinal ailments.
In June 2019, Glaukos signed a definitive agreement and plan of merger to acquire Dose Medical.