Glaukos has announced that the Therapeutic Goods Administration (TGA) of Australia has granted regulatory approval for the Preserflo Microshunt. The device is intended for the reduction of intraocular pressure (IOP) for patients with primary open-angle glaucoma (POAG) where IOP remains uncontrollable with maximum tolerated medical therapy or where glaucoma progression warrants 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,” said Thomas Burns, Glaukos president and CEO. “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.”
Made of a proprietary, biocompatible material, poly(styrene-block-isobutylene-block-styrene) (SIBS), the Microshunt is a flexible, 8.5mm-long tube with planar fins to help affix the device in the tissue through a micro-incision.
Glaukos plans to commence initial commercial launch activities for the Microshunt in Australia in late 2021, with a full commercial launch targeted in mid-2022 following the establishment of formal reimbursement.