SAN DIEGO--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, announced today that its products will be featured in numerous presentations at the annual American Glaucoma Society (AGS) meeting being held at the Hotel Del Coronado in San Diego, California on March 2 – 5, 2017.
“The upcoming surgeon presentations at the AGS meeting represent a diverse collection of clinical studies evaluating the efficacy of one or multiple iStent® devices used in conjunction with cataract surgery or in standalone procedures,” said Thomas Burns, Glaukos president and chief executive officer. “Collectively, these studies illustrate our goal to create a comprehensive suite of micro-scale solutions that can be used individually or as part of a larger treatment algorithm to manage a full range of glaucoma patients’ needs.”
Key Presentation Topics (Pacific Time):
Thursday, March 2, 2017
Poster
Presentations: 7:00am
- Jason Smart, MD – Standalone implantation of two trabecular micro-bypass stents in eyes with OAG on one preoperative medication: outcomes through 48 months
- Robert Fechtner, MD – Four-year results of a prospective, randomized study of two trabecular micro-bypass stents vs. prostaglandin in newly diagnosed open-angle glaucoma
- Mark Gallardo, MD – Two-year outcomes of phacoemulsification with trabecular micro-bypass stent implantation in a predominantly Hispanic population with cataract and POAG
- L. Jay Katz, MD – Titrated IOP control with one, two, or three trabecular micro-bypass stents for OAG: long-term outcomes
- Steven Vold, MD – Outcomes through two years following MIGS with two second-generation trabecular bypass stents in eyes with open-angle glaucoma taking one medication
- Hady Saheb, MD – Long-term outcomes of post-trabeculectomy refractory glaucoma treated with two trabecular micro-bypass stents, one suprachoroidal stent, and a postoperative prostaglandin
- Steven Sarkisian, MD – Treatment with two second-generation trabecular bypass stents together with postoperative prostaglandin in eyes with OAG taking two preoperative medications: 30-month report
- Michael Stiles, MD – Personal experience with trabecular micro-bypass stent implantation during cataract surgery in patients with prior medical and/or surgical therapy for glaucoma
The AGS is comprised of glaucoma specialists and industry professionals committed to the efficacy and advancement of glaucoma management worldwide. Glaukos will be exhibiting at booth T3 on the showroom floor.
Glaukos pioneered Micro-Invasive Glaucoma Surgery (MIGS), which involves the insertion of a micro-scale device from within the eye's anterior chamber through a small corneal incision. The MIGS device reduces intraocular pressure by restoring the natural outflow pathways for aqueous humor. In 2012, Glaukos received U.S. Food & Drug Administration (FDA) approval and launched its first MIGS device, the iStent® Trabecular Micro-Bypass Stent, which has been shown to lower intraocular pressure in adult patients with mild-to-moderate open-angle glaucoma undergoing cataract surgery.
The company’s next-generation MIGS device, the iStent inject® Trabecular Micro-Bypass Stent, includes two stents preloaded in an auto-injection mechanism that allows an ophthalmic surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point. The iStent inject has been approved in the European Union, Australia, Brazil and Canada. Glaukos has also developed the iStent Supra® Suprachoroidal Micro-Bypass Stent, which is designed to reduce intraocular pressure by accessing the suprachoroidal space in the eye and is approved in the European Union. The company has IDE clinical trials underway in the United States for two versions of the iStent inject, one for use in conjunction with cataract surgery and another for use in a standalone procedure. A U.S. IDE clinical trial is also underway for the iStent Supra device.
About iStent® Trabecular Micro-Bypass
Indication for Use: The iStent® Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication.
Contraindications: The iStent® is contraindicated in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
Warnings: Gonioscopy should be performed prior to surgery to exclude PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. The iStent® is MR-Conditional, meaning that the device is safe for use in a specified MR environment under specified conditions; please see label for details.
Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent® has not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, chronic inflammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg after “washout” of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract.
Adverse Events: The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ≥ 1 line at or after the 3 month visit (7%), posterior capsular opacification (6%), stent obstruction (4%), early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event information.
Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications, warnings, precautions, and adverse events.
About Glaukos Corporation
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures to transform the treatment of glaucoma, one of the world’s leading causes of blindness. 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 July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA. (www.glaukos.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, our ability to receive additional approvals of our products, including, without limitation, the iStent inject and iStent Supra, by the FDA and other regulatory bodies; and the continued efficacy of our products as might be suggested in the symposium and poster presentations at the AGS meeting. These and other known risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission. 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.
