Multiple Surgeon Presentations to Showcase Glaukos Products at 2018 European Society of Cataract and Refractive Surgeons Congress
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Sep 21, 2018--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 included in various physician presentations at the 36th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) on September 22-26, 2018, at the Messe Wien Exhibition and Congress Center in Vienna, Austria.
The yearly ESCRS congress is a unique gathering of physicians, ophthalmic industry leaders and others. The meeting assists in sharing and advancing new and compelling data to facilitate conversations regarding best practices, surgical pearls, outstanding patient care, education and advocacy, and new and upcoming technologies.
Key Presentations (CEST):
Saturday, September 22 Presented Poster Session 3:00-4:30pm, Poster Village, Pod 24:10pm – Evaluation of second-generation trabecular micro-bypass stents in patients with mild to severe glaucoma: a Canadian study Presenting Author: P. Harasymowycz
Sunday, September 23 Free Paper Session: Cataract Surgery and Glaucoma 2:00-4:00pm, Room A3, Podium 12:30pm – A prospective randomized U.S. IDE pivotal study of second-generation trabecular micro-bypass stents implanted in conjunction with cataract surgery Presenting Author: T. Samuelson 2:58pm – Single-surgeon experience with ab interno trabecular micro-bypass stent implantation with concomitant cataract surgery in a predominantly Hispanic patient population with primary open-angle glaucoma (OAG): two-year outcomes Presenting Author: M. Gallardo
Monday, September 24 Free Paper Session: Glaucoma and Posterior Segment 8:00-10:30am, Room A3, Podium 18:30am – Outcomes through 60 months following standalone implantation of two trabecular micro-bypass stents in eyes with OAG not controlled on one medication Presenting Author: E. Donnenfeld
Presented Poster Session 9:30-11:00am, Poster Village, Pod 39:30am – Micro-Invasive Glaucoma Surgery (MIGS) with second-generation trabecular micro-bypass stents combined with topical prostaglandin in eyes with OAG on two preoperative medications: 42-month outcomes Presenting Author: B. Ang
E-Posters (Viewable at eTerminals located in the Poster Village)Prospective, randomized Phase 2 study evaluating the safety and efficacy of travoprost intraocular implants Author: R. Ang Long-term intraocular pressure (IOP) control with one, two or three trabecular micro-bypass stents for OAG: 54-month outcomes Author: A. Carceller Guillamet Single-surgeon experience with second-generation trabecular micro-bypass stents: long-term outcomes following implantation in patients with OAG Authors: I. Conrad-Hengerer, G. Auffarth Initial results after implantation of second-generation trabecular micro-bypass stents in a combined cataract and glaucoma procedure Author: K. Gundersen Treatment with standalone implantation of two trabecular micro-bypass stents combined with topical prostaglandin in OAG on two preoperative medications: five-year outcomes Author: A. Junemann Evaluation of MIGS with trabecular micro-bypass stents during cataract surgery in one of the largest cohorts of single-surgeon reports Author: E. Liang IOP reduction after combined phaco and iStent inject in phakic eyes and standalone iStent inject in pseudophakic eyes: preliminary results Authors: M. Pavel, A. Nagar MIGS with second-generation trabecular micro-bypass stents in OAG on one preoperative medication: 42-month outcomes Author: M. Toteberg-Harms Five-year outcomes of two trabecular micro-bypass stents vs. prostaglandin in newly diagnosed OAG Author: S. Vold
Glaukos pioneered MIGS, which involves insertion of a micro-scale device from within the eye’s anterior chamber through a small corneal incision. The MIGS device is 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 and South Africa.
In addition, Glaukos is pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the U.S.
Glaukos at ESCRS
Glaukos will be exhibiting on the showroom floor at booth #B330.
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.
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 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.
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 of our products as might be suggested in the presentations at the ESCRS meeting. These 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 June 30, 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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CONTACT: Glaukos Corporation
Director, Investor Relations, Corporate Development & Strategy
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SOURCE: Glaukos Corporation
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PUB: 09/21/2018 07:00 AM/DISC: 09/21/2018 07:01 AM