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  • Glaukos Announces Market-Leading Clinical Milestone of 200 Peer-Reviewed Publications on iStent® Technologies

Glaukos Announces Market-Leading Clinical Milestone of 200 Peer-Reviewed Publications on iStent® Technologies

By on August 23, 2021 0

SAN CLEMENTE, Calif .– (COMMERCIAL THREAD) – Glaukos Corporation (NYSE: GKOS), an ophthalmic and pharmaceutical medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced a milestone without precedent of clinical data from 200 peer-reviewed publications highlighting the efficacy and safety of iStent® technologies around the world. This achievement represents the largest, most diverse, and longest-term body of clinical data for any MIGS procedure. Several points of note in this industry-leading body of clinical evidence include:

  • Over 20,000 eyes have been analyzed in a wide range of studies spanning nearly 20 years.

  • 183 publications detail studies carried out independently and initiated by researchers.

  • 11 studies are prospective, randomized, controlled trials (RCTs).

  • Over 50 of the publications highlight studies in a patient population with autonomic glaucoma, with 20 meta-analyzes and 14 cost-benefit studies demonstrating the effectiveness of payer and practice.

  • 15 publications analyze outcome data over 4 to 8 years, establishing the broadest and longest follow-up of any MIGS procedure.

  • Independent research from over 20 countries has been published demonstrating efficacy and safety in a wide variety of patient populations with varying degrees of glaucoma (ocular hypertension with advanced / refractory disease).

  • First and only MIGS procedure to demonstrate improvement in patient quality of life from a pivotal trial.

In addition, the official publication of the World Glaucoma Association, the Glaucoma Journal, selected a study on iStent and iStent inject® as July 2021 article. In this systematic review and meta-analysis by Dr Paul Healey, a total of 13 studies were analyzed to assess the independent effect of iStent and iStent inject without cataract surgery, including four randomized controlled trials and nine non-randomized (single-arm) studies providing data on 778 eyes. In eyes implanted with iStent devices, a reduction in weighted mean intraocular pressure (IOP) of 31.1% was observed at 6-12 months. In studies reporting longer term results, the weighted mean reduction in IOP was 30.4% and 32.9% at 36-48 months and 60 months, respectively. The weighted mean reduction in IOP from baseline in all studies at 6-12 months and 36-60 months after stent implantation was 7.0 mmHg and 6.6 mmHg, respectively. Drug load was reduced by approximately 1.0 drug at 6-18 months and from 1.2 drug at 36-60 months.

“Since the inception of Glaukos Corporation, our goal has been to transform the treatment of chronic and debilitating eye diseases through the development of innovative and sustainable therapies,” said Thomas Burns, President and CEO of Glaukos. “Scientific evidence and clinical rigor have been at the heart of our organization, with the first publication on iStent for the treatment of glaucoma dating back to 2002, two years before the onset of the first iStent pivotal test. Nearly 20 years later, we apply the same rigor and integrity to our business as we remain focused on generating strong clinical evidence, as evidenced by this groundbreaking achievement of 200 peer-reviewed publications. I am grateful to our customers and employees around the world who have dedicated countless hours to this market leading achievement to support our iStent technologies for the benefit of patients around the world.

“As one of the first users and researchers of the first iStent pivotal test, I saw firsthand how iStent, as the first MIGS device, fundamentally revolutionized the way we treat glaucoma today, ”said Thomas W. Samuelson, MD, surgeon with Minnesota Eye Consultants and assistant professor at the University of Minnesota. “Glaukos has focused on generating high quality clinical evidence to support adoption of MIGS procedures since day one and has continued to do so for the past 20 years. I look forward to Glaukos’ continued innovation and exciting new product launches to come.

“Each evolution, from iStent To iStent inject and now at iStent inject W, was a transition to make the procedure more predictable and efficient, ”said Ike Ahmed, MD, director of research at the Kensington Eye Institute and director of the Glaucoma and the Advanced Anterior Segment Fellowship Program at the University of Toronto. “In my practice, iStent and iStent inject clinical results have stood the test of time as I regularly see patients over 10 years lateriStent surgery in which glaucoma is still well managed. The high security and versatility of iStent technologies make it our most commonly used MIGS procedure in mild to moderate open-angle glaucoma.

Glaukos remains dedicated to innovation and brings cutting-edge technologies to its customers around the world to serve their patients, continuing to invest more than 30% of its turnover in R&D, including the development of new products. A significant number of clinical studies for current and future products are ongoing, with additional studies starting in the near future.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic and pharmaceutical medical technology company specializing in 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 paradigm of glaucoma treatment and management. Glaukos launched the iStent, its first MIGS device, in the United States in 2012, its new generation iStent inject in the United States in 2018, and more recently the iStent inject W in 2020. In corneal health, Glaukos’ exclusive line of single-use bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen crosslinking to treat corneal ectatic disorders and correcting the refractive conditions. Glaukos leverages its technology platform to create a comprehensive and exclusive portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal diseases.

Forward-looking statements

All statements other than statements of historical fact included in this press release that deal with activities, events or developments that we expect, believe or anticipate will occur or may occur in the future are forward-looking statements. While we believe we have a reasonable basis for the forward-looking statements contained herein, we caution you that they are based on current expectations regarding future events affecting us and are subject to risks, uncertainties and factors. related to our operations and our business environment, most of which are difficult to predict and many of which are beyond our control, which may cause our actual results to differ materially from those expressed or implied by the forward-looking statements contained in this press release. These potential risks and uncertainties include, but are not limited to, the timing and extent of obtaining regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain financial coverage. and adequate reimbursement for our products, and the continued efficacy and safety profile of our products, as might be suggested in these publications. These and other risks, uncertainties and factors relating to Glaukos and our business are described in detail under the heading “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which was filed with the Securities and Exchange Commission (SEC) on August 5, 2021, and our annual report on Form 10-K for the fiscal year ended December 31, 2020, which was filed with the SEC on March 1, 2021. Our documents filed with the Securities and Exchange Commissions are available in the Investors section of our website at www.glaukos.com or to www.sec.gov. In addition, information on 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 any forward-looking statements in this press release, which speak only as of the date hereof. We assume no obligation to update, modify or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under securities laws. applicable movable property.


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