Glaukos Announces Australia’s TGA Regulatory Approval for PRESERFLO™ MicroShunt

Wednesday, June 09, 2021

Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that the Therapeutic Goods Administration (TGA) of Australia has granted regulatory approval for the PRESERFLO MicroShunt intended for the reduction of intraocular pressure (IOP) in eyes of patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/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 chief executive officer. “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.”

The PRESERFLO MicroShunt is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications or where glaucoma progression warrants surgery. IOP reduction is the most effective means of preventing the progression of glaucoma and vision loss. Made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], the PRESERFLO MicroShunt is a flexible, 8.5-mm-long tube with planar fins to help fixate the device in the tissue through a micro-incision and prevent leakage and migration.

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.

Under its current development and commercialization license agreement with Santen Pharmaceutical Co., Ltd. (Santen), Glaukos has exclusive commercialization and development rights for the MicroShunt in Australia. In addition, Glaukos also has exclusive commercialization rights and control of all development activities, including over clinical development and regulatory affairs activities, for the MicroShunt in the United States, Canada, New Zealand, Mexico, Brazil and the remainder of Latin America.

Latest Issue
Get instant
access to our latest e-book