Glaukos Technologies Featured in Numerous Presentations at 2019 American Glaucoma Society Meeting

Business Wire 13-Mar-2019 4:15 PM

Glaukos Corporation (NYSE:GKOS), an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, announced today that its products will be featured in various presentations at the American Glaucoma Society (AGS) Annual Meeting on March 14-17, 2019 at the Marriott Marquis Hotel in San Francisco.

Glaukos is sponsoring an educational symposium for surgeons during AGS entitled "The New Dawn of MIGS: Devices, Data and Techniques" on March 15, 2019 at 1:15 to 2:15 PDT in the Soma Room of the Marriott Marquis Hotel. The faculty includes Ike Ahmed, MD (Moderator); Mark Gallardo, MD; Davinder Grover, MD; and Nate Radcliffe, MD. Go here to register.

Glaukos will also be exhibiting on the showroom floor throughout AGS at booth #B6.

In addition, key surgeon poster presentations available for viewing on March 14, 2019 include:

• One-Year Outcomes of Combined Phaco and Collector Channel Targeting with Two Second-Generation Trabecular Bypass Stents (iStent inject^®) (PO001)Author: Paul Harasymowycz, MD
• Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in Pseudoexfoliative Glaucoma: Long-Term Results (PO004)Authors: Tanner J. Ferguson, MD; Vance Thomson, MD; John Berdahl, MD
• Five-Year Outcomes of a Study Evaluating One, Two or Three Trabecular Micro-Bypass Stents for Open-Angle Glaucoma (OAG) (PO017)Author: Oluwatosin U. Smith, MD
• Three-Year Outcomes of Phacoemulsification with Implantation of Two First-Generation Trabecular Micro-Bypass Stents in Patients with OAG (PO018)Authors: Lucy Ma, Won I. Kim, MD
• Investigating Pre-Operative Factors that Predict Trabecular Meshwork Bypass Procedure Outcomes (PO022)Authors: Jason Flamendorf, MD; Jonathan S. Myers, MD; Daniel Lee, MD
• Long-Term Performance of Second-Generation Trabecular Micro-Bypass Stents (iStent inject) Implanted in Patients with Glaucoma: Four-Year Outcomes (PO025)Authors: Fritz H. Hengerer, MD; Jay L. Katz, MD
• Intermediate-Term Outcomes of First-Generation Trabecular Micro-Bypass Stents and Second-Generation Stents in Combination with Phacoemulsification (PO026)Authors: Taylor T. Lukasik, MD; Ike K. Ahmed, MD
• Single-Surgeon Experience with iStent^® Trabecular Micro-Bypass Implanted in Conjunction with Cataract Surgery: Long-Term Outcomes (PO035)Authors: Richard A. Supnet, MS; Mark J. Gallardo, MD
• Medium-Term Outcomes of Multiple Trabecular Micro-Bypass Stents in Combination with Phacoemulsification (PO038)Authors: Nicholas H. Andrew, MBBS; Ike K. Ahmed, MD
• A Prospective, Randomized Pivotal Study of Second-Generation Trabecular Micro-Bypass Stents (iStent inject) Implanted in Conjunction with Cataract Surgery (PO042)Author: Inder P. Singh, MD
• Evaluating Minimally Invasive Glaucoma Surgery with Trabecular Micro-Bypass Stents in African American Glaucoma Patients (PO044)Authors: Albert Bargoud, BA; Selena J. An, MSPH; Leon W. Herndon, MD; Albert S. Khouri, MD

Glaukos pioneered MIGS, which involves insertion of a micro-scale device from within the eye's anterior chamber through a small corneal incision. Glaukos MIGS devices are designed to reduce IOP by restoring the natural outflow pathways for aqueous humor. In 2012, Glaukos received U.S. Food and Drug Administration (FDA) approval and launched its first MIGS device, the iStent Trabecular Micro-Bypass Stent.

The company's second-generation MIGS device, the iStent inject Trabecular Micro-Bypass System, was approved by the FDA in June 2018. The iStent inject includes two stents preloaded in an auto-injection mechanism that allows an ophthalmic surgeon to inject stents into multiple locations of the trabecular meshwork through a single corneal incision. The iStent inject has also been approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and other international markets. Glaukos is also pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.

About iStent inject Trabecular Micro-Bypass System (U.S.)

Indication for Use: The iStent inject Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma.

Contraindications: The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber angle, retrobulbar tumor, thyroid eye disease, or 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 congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.

MRI Information: The iStent inject is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.

Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents.

Adverse Events: Common postoperative adverse events reported in the randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss = 2 lines = 3 months (2.6% vs. 4.2%).

Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.

For more information, visit www.glaukos.com.

About iStent Trabecular Micro-Bypass Stent (U.S.)

Indication for Use: The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of 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

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed 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 launched its next-generation iStent inject device in the United States in September 2018. Glaukos 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 inject, measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA.

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 extent to which our products may obtain regulatory approval and market acceptance, and the continued efficacy and safety profile of our products as might be suggested in the presentations at the AGS meeting. These risks, uncertainties and factors are described in detail under the caption "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 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.

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