Supporting the Most Robust, Diverse and Longest-Term Body of Clinical Evidence for Any MIGS Technology
Multiple 5-, 6-, 7- and 8-Year Real-World Studies Published, Demonstrating Leading Efficacy & Safety Across the Entire Glaucoma Disease Spectrum
Outcomes Reinforce the Powerful Benefit/Risk Calculus of iStent Technologies’ Micro-invasive, Tissue-Sparing Approach, Supporting the More Than 800,000 iStent Procedures Performed Globally to Date
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, announced today an unprecedented clinical data milestone of 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 market-leading body of clinical evidence include:
- Over 20,000 eyes have been analyzed in a wide range of studies over nearly 20 years.
- 183 publications detail independently conducted, investigator-initiated studies.
- 11 studies are prospective, randomized, controlled trials (RCTs).
- More than 50 of the publications highlight studies in a standalone glaucoma patient population, with 20 meta-analyses and 14 cost-effectiveness studies demonstrating payor and practice efficiency.
- 15 publications analyze 4- to 8-year outcomes data, establishing the largest and longest-term follow up of any MIGS procedure.
- Independent research from more than 20 countries has been published, demonstrating efficacy and safety in highly diverse patient populations with varying degrees of glaucoma (ocular hypertension through advanced/refractory disease).
- First and only MIGS procedure to demonstrate improved patient quality of life from a pivotal trial.
In addition, the official publication of the World Glaucoma Association, the Journal of Glaucoma, selected a study on iStent and iStent inject® as its July 2021 Paper of the Month. In this systematic review and meta-analysis authored by Dr. Paul Healey, a total of 13 studies were analyzed to evaluate 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 weighted mean intraocular pressure (IOP) reduction of 31.1% was observed at 6-12 months. In studies reporting longer-term outcomes, the weighted mean IOP reduction was 30.4% and 32.9% at 36-48 months and 60 months, respectively. The pooled weighted mean IOP reduction from baseline across all studies at 6-12 months and 36-60 months post-stent implantation was 7.0 mmHg and 6.6 mmHg, respectively. Medication burden was reduced by approximately 1.0 medication at 6-18 months, and by 1.2 medications at 36-60 months.
“Since the inception of Glaukos Corporation, our goal has been to transform the treatment of chronic, debilitating eye diseases through development of novel, sustainable therapies,” said Thomas Burns, Glaukos president and chief executive officer. “Scientific evidence and clinical rigor have been at the heart of our organization, with the earliest publication on iStent for the treatment of glaucoma dating back to 2002, two years prior to the initiation of the original iStent pivotal trial. Nearly 20 years later, we apply this same rigor and integrity to our business as we remain focused on generating strong clinical evidence, demonstrated by this trailblazing accomplishment of 200 peer-reviewed publications. I am grateful for our customers and employees around the world who have poured countless hours into this market-leading achievement to support our iStent technologies for the benefit of patients worldwide.”
“As one of the early adopters and investigators in the original iStent pivotal trial, I have experienced first-hand how iStent, as the first MIGS device, has fundamentally revolutionized the way we treat glaucoma today,” said Thomas W. Samuelson, MD, surgeon at Minnesota Eye Consultants, and Adjunct Professor at the University of Minnesota. “Glaukos has been focused on generating high-quality clinical evidence to support the uptake of MIGS procedures since day 1 and has continued to do so over the last 20 years. I am looking forward to Glaukos’s continued innovation and exciting new product launches ahead.”
“Each evolution, from iStent to iStent inject and now to iStent inject W, has been a transition to making the procedure more predictable and effective,” said Ike Ahmed, MD, Research Director at the Kensington Eye Institute and Director of the Glaucoma and Advanced Anterior Segment Surgery Fellowship Program at the University of Toronto. “In my practice, iStent and iStent inject clinical outcomes have stood the test of time as I routinely see patients over 10 years post-iStent surgery whose glaucoma is still well-managed. The high safety and versatility of iStent technologies make this our most commonly used MIGS procedure in mild-moderate open-angle glaucoma.”
Glaukos remains dedicated to innovation and bringing customers around the world best-in-class technologies to serve their patients, continuing to invest upwards of 30% of revenue back into R&D, including new product development. A significant number of clinical studies for both current and future products are ongoing, with additional studies commencing in the near future.
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.
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 timing and extent to which obtain regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and 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 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 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 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.