Business Wire08.19.21
Glaukos Corporation, an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, 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 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.”
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.
Glaukos is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012, its next-generation iStent inject device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.
“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.”
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.
Glaukos is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012, its next-generation iStent inject device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.
