Therapeutic Goods Administration of Australia approves PreserFlo microshunt
The PreserFlo microshunt was given regulatory approval from the Therapeutic Goods Administration of Australia, according to a press release from Glaukos.
The microshunt is intended to reduce IOP in patients with primary open-angle glaucoma whose disease is uncontrolled on maximum medical therapy or whose disease progression warrants surgical intervention.
“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,” Thomas Burns, president and chief executive officer of Glaukos, said in the 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.”
In Australia, Glaukos intends to launch commercial activities for the microshunt in late 2021, following up with another launch in mid-2022 once formal reimbursement is established. Elsewhere, Glaukos has “exclusive commercialization rights and control of all development activities” regarding the microshunt in the United States, Canada, New Zealand and countries of Latin America, the release said.