Glaukos Announces Australia’s TGA Regulatory Approval for PRESERFLO™ MicroShunt
Glaukos Corporation (NYSE: GKOS) has received regulatory approval from Australia's Therapeutic Goods Administration (TGA) for its PRESERFLO MicroShunt. This device is designed to reduce intraocular pressure in patients with primary open-angle glaucoma, providing an alternative to conventional surgeries. Glaukos plans to initiate commercial activities for the MicroShunt in late 2021, targeting a full launch by mid-2022, contingent on reimbursement. The company maintains exclusive commercialization rights for the MicroShunt across several key markets, including Australia and the Americas.
- Regulatory approval from Australia's TGA for the PRESERFLO MicroShunt.
- Plans to launch the MicroShunt commercially in late 2021 and fully by mid-2022.
- Exclusive commercialization rights in Australia and multiple regions in the Americas.
- None.
Glaukos Corporation (NYSE: GKOS), 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.
About Glaukos
Glaukos (www.glaukos.com) 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.
About Santen
As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing and sales of pharmaceuticals, over-the-counter products and medical devices, and its products now reach patients in over 60 countries. Toward realizing “WORLD VISION” (Happiness with Vision), the world Santen ultimately aspires to achieve, as a “Social Innovator”, the company aims to reduce the social and economic opportunity loss of people around the world caused by eye diseases and defects by orchestrating and mobilizing key technologies and players around the world. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (www.santen.com).
Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the continued efficacy and safety profile of our products, including the PRESERFLO MicroShunt, the extent to which we may obtain regulatory approval for the MicroShunt in other markets, our ability to successfully commercialize such products in accordance with our targeted launch plans, and the ability to obtain adequate financial coverage and reimbursement. These and other risks, uncertainties and factors related to Glaukos and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which was filed with the Securities and Exchange Commission (SEC) on May 6, 2021, and our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 1, 2021. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
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FAQ
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