Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia’s Therapeutic Goods Administration for its Preserflo MicroShunt.
The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or where glaucoma progression needs surgery.
“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,” president and CEO Thomas Burns said in a news release. “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. We are excited for the opportunity to leverage our best-in-class sales organization to bring this novel technology to patients in Australia.”
MicroShunt is an ab-externo drainage system that drains eye fluid. It is a flexible 8.5 mm length tube with planar fins that help fixate the device in the tissue through a micro-incision and prevent leakage and migration.
Glaukos said it plans to commence an initial commercial launch of the device in Australia later this year, with a full launch expected in mid-2022.