Surgeons to Present Recent Personal Experience Data and Clinical Results at Annual European Anterior Segment Conference
BARCELONA, Spain--(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 its products will be featured in nine Key Opinion Leader (KOL) presentations at the XXXIII Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Barcelona, Spain on September 5 – 9, 2015 at the Fira Barcelona Gran Via.
The ESCRS is Europe's leading organization for cataract and refractive surgeons. With over 5,000 members from almost 100 countries worldwide, the ESCRS offers a unique forum for discussion and learning, which ensures that international expertise is shared by ophthalmologists all over Europe.
Presentation Topics by Day and Time (Central European Time, CET):
Saturday, September 5, 2015
1. 8:48 am – 8:54 am – Tobias Neuhann, MD – Long-term postoperative results following implantation of a single trabecular bypass stent during small incision cataract surgery in patients with glaucoma or ocular hypertension
Location: Main Auditorium, Free paper presentation
2. 9:00 am – 9:06 am – George Beiko, MD – Cataract surgery combined with trabecular micro bypass stent implantation in patients with open-angle glaucoma: 3 year follow-up
Location: Main auditorium, Free paper presentation
Monday, September 7, 2015
3. 2:50 pm – 3:00 pm – David Chang, MD – Long-term findings following Micro-Invasive Glaucoma Surgery (MIGS) with two trabecular micro-bypass stents and travoprost in OAG not controlled on two preoperative medications
Location: Pod 1, Moderated poster presentation
Tuesday, September 8, 2015
4. 8:06 am – 8:12 am – Robert Cionni, MD – Personal experience through two years with a trabecular micro-bypass stent during cataract surgery to manage IOP and reduce medication burden in patients with open-angle glaucoma (OAG) and cataract
Location: Room 17, Free Paper Presentation
5. 8:12 am – 8:18 am – Matthias Klamann, MD – iStent inject in phakic open-angle glaucoma
Location: Room 17, Free Paper Presentation
6. 8:18 am – 8:24 am – Anselm Jünemann, MD – Refractory open-angle glaucoma treated with two trabecular micro-bypass stents, one suprachoroidal stent and prostaglandin
Location: Room 17, Free Paper Presentation
7. 8:24 am – 8:30 am – J. Gonnermann, MD – Contralateral eye comparison study in MIGS: Trabectome vs. iStent inject
Location: Room 17, Free Paper Presentation
8. 8:30 am – 8:36 am – Gerd Auffarth, MD – Prospective, randomized comparison of one vs. two trabecular micro-bypass stents implanted during cataract surgery in subjects with cataract and open-angle glaucoma on one preoperative ocular hypotensive medication: results through month 18
Location: Room 17, Free Paper Presentation
Electronic Poster
9. Antonio Fea, MD – Efficacy and safety outcomes through 18 months from prospective, randomized, comparative study in OAG patients of implantation of 1, 2 or 3 trabecular micro-bypass stents as a sole procedure
Location: Accessible on computer terminal in Congress Centre
Glaukos pioneered 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®, 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 also developed the iStent Supra® Suprachoroidal Micro-Bypass Stent, which is designed to reduce intraocular pressure by accessing the suprachoroidal space in the eye and is approved in the European Union. The company has IDE clinical trials underway in the United States for two versions of the iStent inject, one for use in conjunction with cataract surgery and another for use in a standalone procedure. A U.S. IDE clinical trial is also underway for the iStent Supra device.
Glaukos at ESCRS
Glaukos will be exhibiting on the showroom floor at the Fira Barcelona Gran Via convention center in Spain from September 5 – 9, 2015 at booth H14. 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 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. These include statements about our plans, objectives, strategies and prospects regarding, among other things, our current product, pipeline technology and corresponding efforts to secure regulatory approvals. 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. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. 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 these forward-looking statements, 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. The 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 and available in the Investor section of our website at www.glaukos.com or at www.sec.gov.
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Source: Glaukos Corporation