12 Podium and Poster Presentations about Glaukos Technologies Scheduled During Annual European Anterior Segment Conference
COPENHAGEN, Denmark--(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 clinical data regarding its products will be presented in 12 Key Opinion Leader (KOL) podium and poster presentations at the annual Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Copenhagen, Denmark on September 10 – 14, 2016.
Presentation Topics by Day and Time (Central European Time, CET):
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Sunday, September 11, 2016
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3:06pm – 3:12pm Fritz Hengerer, MD - Personal experience and outcomes through one year following implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma
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Location: Auditorium C6, Free Paper Session
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Monday, September 12, 2016
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8:00am – 8:06am Antonio Fea, MD – Reduced IOP and medication burden through 30 months: prospective, randomized, comparative study in OAG patients of implantation of 1, 2 or 3 trabecular micro-bypass stents as a sole procedure
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Location: Hall C4, Glaucoma II
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9:38am– 9:44am M. Braun, MD – Comparison of the IOP lowering effect of cataract surgery in combination with microinvasive glaucoma surgery (MIGS)
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Location: Hall C4, Glaucoma II
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Tuesday, September 13, 2016
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2:00pm – 2:06pm Tobias Neuhann, MD – Continued long-term results after implantation of a single trabecular bypass stent during small incision cataract surgery in patients with glaucoma or ocular hypertension
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Location: Auditorium C6
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Poster Abstracts
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Gerd Auffarth, MD – Three-year outcomes from prospective, randomized study of micro-invasive glaucoma surgery (MIGS) with two trabecular stents vs one prostaglandin in newly diagnosed open-angle glaucoma
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Milena Kozera, MD – Mid-term assessment of findings following implantation of a trabecular micro-bypass stent and cataract surgery via phacoemulsification in patients with mild-moderate open-angle glaucoma and cataract
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A. Nagar, MD – Intraocular pressure reduction after combined phacoemulsification and iStent implantation
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Konrad Schargel, MD – Analysis of refractive changes in patients with phacoemulsification plus iStent vs phacoemulsification
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Jose Belda, MD – Eighteen-month postoperative outcomes following implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma not controlled by one preoperative medication
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Johannes Gonnermann, MD – Contralateral eye comparison study in MICS and MIGS: Trabectome® vs iStent inject® (one-year results)
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Anselm Jünemann, MD – Second generation trabecular micro-bypass stents and one postoperative prostaglandin in patients with open-angle glaucoma not controlled with two preoperative medications
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Matthias Klamann, MD – iStent inject as stand-alone procedure in phakic open angle glaucoma: first clinical annual results
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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 (IOP) 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 and Canada. Glaukos has U.S. IDE clinical trials underway for two versions of the iStent inject, one for use in conjunction with cataract surgery and another for use as a standalone procedure. 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. Approved in the European Union, the iStent Supra is also being evaluated in a U.S. IDE clinical trial.
Glaukos at ESCRS
Glaukos will be exhibiting on the showroom floor at the Bella Center convention center in Copenhagen, Denmark from September 10 – 14, 2016 at booth CN24. Additional information on the venue can be obtained HERE.
About iStent® Trabecular Micro-Bypass (U.S.)
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.
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 ESCRS podium and poster presentations. 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 June 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.
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Source: Glaukos Corporation