Glaukos has secured Australian regulatory approval for the Preserflo MicroShunt, offering late-stage glaucoma patients a more elegant surgical alternative to conventional filtration procedures.
The ophthalmic medical technology and pharmaceutical company announced the Therapeutic Goods Administration (TGA) has cleared the implant that is intended for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where disease progression warrants surgery.
Glaukos is planning an initial commercial launch in Australia in late 2021, with a full commercial launch targeted in mid-2022 following confirmation of formal reimbursement.
“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,” Mr Thomas Burns, Glaukos president and CEO, said.
“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 organisation to bring this novel technology to patients in Australia.”
The technology is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma.
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.
Under its current development and commercialisation license agreement with Santen Pharmaceutical, Glaukos has exclusive commercialisation and development rights for the MicroShunt in Australia.
In addition, Glaukos also has exclusive rights and control of all development activities, including over clinical development and regulatory a airs activities, for the MicroShunt in the US, Canada, New Zealand, Mexico, Brazil and the remainder of Latin America.