Glaukos Istent Products To Be Showcased At 2017 European Society Of Cataract And Refractive Surgery
Published: Oct 06, 2017
Surgeons to Present Recent Data and Clinical Results at European Anterior Segment Conference
SAN CLEMENTE, Calif.--(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 various Key Opinion Leader (KOL) presentations and electronic posters will feature its iStent® Trabecular Micro-Bypass and iStent inject® Trabecular Micro-Bypass products at the upcoming European Society of Cataract and Refractive Surgery (ESCRS) annual congress on October 7 – 11, 2017 in Lisbon, Portugal.
The yearly congress held by the ESCRS 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.
Presentations (Greenwich Mean Time, GMT):
Monday, October 9, 2017
Free Paper Session: Glaucoma
8:00 – 10:30, Room 4.1
9:18am – The iStent trabecular micro-bypass stent reduces post
cataract surgery intraocular pressure (IOP) spikes in advanced glaucoma
Authors: G. Moussa, P. Pandey, S. Begum, I. Masood
9:54am – MIGS with two second generation trabecular bypass stents in
eyes with primary open-angle glaucoma on one preoperative medication:
outcomes through two years
Authors: K. Schargel, J. Belda Sanchis, J. Ruiz Colecha, J. Campello
Electronic Posters (Viewable at eTerminals located in the Poster Village)
Outcomes in mild, moderate and severe glaucoma through two years
following phacoemulsification with trabecular micro-bypass stent
implantation in a predominantly Hispanic population
Authors: M. Gallardo, R. Supnet
Treatment with two second-generation trabecular micro-bypass stents
and postoperative topical prostaglandin in eyes with open-angle
glaucoma taking two preoperative medications: outcomes through 30
Authors: J. Martinez de la Casa
IOP reduction following iStent inject implantation in primary
open-angle glaucoma eyes depending on lens condition and further
Authors: F. Ruefer, M. Matthäi, J. Forster, T. Herbst, D. Holland
Pilot series of Southeast Asian eyes which underwent combined iStent
trabecular micro-bypass device implantation and cataract surgery
Authors: C. Sng, S. Loon, P. Chew
Long-term titrated IOP control and medication reduction following
implantation of one, two, or three trabecular micro-bypass stents
Author: L. Voskanyan
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. The MIGS device is designed to reduce IOP by restoring the natural outflow pathways for aqueous humor. In 2012, Glaukos received FDA approval and launched its first MIGS device, the iStent, which has been shown to lower IOP in adult patients with mild-to-moderate open-angle glaucoma.
The company’s next-generation MIGS device, 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 been approved in the European Union, Australia, Brazil and Canada. Glaukos has U.S. IDE clinical trials underway for the iStent inject for use in conjunction with cataract surgery and for a similar product, the iStent SA™, for use as a standalone procedure. Glaukos has also developed the iStent Supra® Suprachoroidal Micro-Bypass Stent, which is designed to reduce IOP by accessing the suprachoroidal space in the eye. Approved in the European Union, the iStent Supra is also being evaluated in a U.S. IDE clinical trial.
The company is also pursuing FDA approval of iDose™ Travoprost, a drug-delivery system designed to elute therapeutic levels of travoprost, a glaucoma drug, from within the anterior chamber for extended periods of time.
Glaukos at ESCRS
Glaukos will be exhibiting on the showroom floor on October 7 – 10, 2017 in the FIL – Feira Internacional de Lisboa at booth #P1128.
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 (www.glaukos.com) is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures 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, measuring 1.0 mm long and 0.33 mm wide, 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 limitations, the continued efficacy of our products as might be suggested in the presentations and posters described herein; the extent to which the company will be able to obtain regulatory approval for its next-generation products; and the extent to which the company’s next-generation products will obtain an indication of use for multiple stents and multiple pathways for aqueous fluid outflow. 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 Annual Report on Form 10-K for 2016 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. 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.