Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, announced today that its products will be featured in various presentations during the annual American Academy of Ophthalmology (AAO) meeting in Chicago, IL, at McCormick Place convention center on October 15–18, 2016.
Glaukos is sponsoring an educational symposium for surgeons entitled “The Complete MIGS Procedure” on Saturday, October 15, 2016, from 5:30 – 7:30 p.m. (CDT) in the Grand Ballroom at the Renaissance Chicago Downtown Hotel. Faculty includes Kerry Solomon, MD; Ike Ahmed, MD; Robert Cionni, MD; Steve Sarkisian, MD; and Jeffrey Whitman, MD.
In addition, Glaukos technologies will be the subject of three scientific poster presentations on Monday, October 17, 2016, as follows:
12:30 p.m. – 2:00 p.m. (CDT), Location: Hall A:
Glaukos will be exhibiting at booth 626 on the showroom floor for the duration of the meeting.
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 is designed to reduce intraocular pressure by restoring the natural outflow pathways for aqueous humor. In 2012, Glaukos received U.S. Food & Drug Administration (FDA) approval and launched the flagship MIGS device, the iStent Trabecular Micro-Bypass Stent®, which has been shown to lower intraocular pressure 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 iStent inject is for investigational use only in the United States, with two IDE clinical trials underway for two versions of the device,one for use in conjunction with cataract surgery and another for use in a standalone procedure. An IDE clinical trial is also underway for the iStent Supra, which is for investigational use only in the United States.
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 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. (www.glaukos.com)
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 symposium and poster presentations at AAO. 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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Last updated on: 06/10/2016
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