Numerous Presentations to Showcase Long-Term Efficacy & Safety of Glaukos Technologies at 2020 American Glaucoma Society Meeting
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Feb 26, 2020--
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retina diseases, announced today that its products will be featured in various presentations at the American Glaucoma Society (AGS) Annual Meeting beginning February 27, 2020 at the Gaylord National Resort & Convention Center in Washington D.C.
Glaukos is hosting an educational symposium for surgeons during AGS entitled “Hot Topics in MIGS: The Evolving Transformation” on February 27 at 12:30 PM – 1:30 PM in the Eastern Shore Room 2 on the first floor of the convention center. The faculty includes Sahar Bedrood, MD; Alex Huang, MD; Paul Singh, MD; and Tom Samuelson, MD, who will moderate the symposium. Go here to register.
Glaukos will be exhibiting on the showroom floor throughout AGS at booth B-5.
Key surgeon poster presentations available for viewing during AGS in the Cherry Blossom Lobby include:
Thursday, February 27
7 :00 AM – 8:00 AM Poster Presentation Session
7:00 AM – 5:00 PM Poster Viewing
- PO002 Sustained Five-Year Safety and Intraocular Pressure (IOP) Outcomes in Open-Angle Glaucoma (OAG) Subjects Treated with Trabecular Micro-Bypass Stents ( iStent inject ® )
Author: Jason Bacharach
- PO014 Five-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents ( iStentinject ) Combined with Travoprost in OAG on Two Preoperative Medications
Authors: Albert Khouri, Lilit Voskanyan, L. Jay Katz
- PO015 The Efficacy of Two Trabecular Micro-Bypass Stents with Phacoemulsification Surgery Compared to Trabeculectomy with Phacoemulsification Surgery
Authors: Michael Lawson, Sean Sykes, Lucy Ma, Jane Whitney, Sorana Raiciulescu, Won Kim, Jonathan Buttram
- PO016 Long-Term Outcomes of iStent ® Trabecular Micro-Bypass Stenting with Cataract Surgery Including Visual Field (VF), Optical Coherence Tomography (OCT) and Disease Progression – Real-World Case Series
Author: Richard Lehrer
- PO030 Outcomes of the iStent Trabecular Micro-Bypass Implant: Three-Year Follow-Up
Authors: Saba Samet, Jeb Ong, Devesh Varma, Iqbal Ike Ahmed
- PO031 Real-World Experience with Second-Generation Trabecular Micro-Bypass Stents ( iStent inject ) Implanted in Conjunction with Phacoemulsification
Author: Steven Sarkisian
- PO037 Early Results of Second-Generation Trabecular Micro-Bypass Stents ( iStent inject ) with Cataract Surgery in a Real-World Setting
Authors: Tyler Wickas, Joshua Kim
- PO045 Second-Generation Trabecular Micro-Bypass Stents ( iStent inject ) with Cataract Surgery in OAG: Single-Surgeon Outcomes
Authors: Michael Hopen, Mark Gallardo
Friday, February 28
7:00 AM – 8:00 AM Poster Presentation Session
7:00 AM – 5:00 PM Poster Viewing
- PO058 Three-Year Outcomes of Trabecular Micro-Bypass Stents ( iStentinject ) Stratified by Prior Glaucoma Surgery
Authors: Fritz Hengerer, L. Jay Katz
Glaukos pioneered Micro-Invasive Glaucoma Surgery (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. Glaukos received FDA approval for its first-generation MIGS device, the iStent, in 2012 . Its second-generation iStent inject, approved by the FDA in 2018, includes two stents preloaded in an auto-injection mechanism that facilitates stent insertion into multiple trabecular meshwork locations through a single corneal incision. The iStent inject is also approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Japan, Korea, New Zealand, Singapore, South Africa and other international markets. Approximately 600,000 iStent and iStent inject devices have been implanted globally to date. Glaukos is 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.
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 July 2012 and launched its next-generation iStent inject® device in the United States in September 2018. 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, which was filed with the Securities and Exchange Commission (SEC) on November 8, 2019. Our filings with the SEC 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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KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
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SOURCE: Glaukos Corporation
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PUB: 02/26/2020 04:30 PM/DISC: 02/26/2020 04:30 PM