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 its products will be featured in numerous presentations at the 28th Annual Meeting of the American Glaucoma Society (AGS) being held at the New York Marriott Marquis in New York City on March 1-4, 2018.
The AGS is comprised of glaucoma specialists dedicated to sharing clinical and scientific information for the benefit of patients, colleagues, fellows and residents. The moderated poster presentations listed below will be held in the Astor Ballroom from 7:00-8:00 a.m. EST, with poster viewing available until 5:00 p.m. EST.
Thursday, March 1, 2018
- Oluwatosin U. Smith, MD – Long-Term Intraocular Pressure (IOP) Control with One, Two or Three Trabecular Micro-Bypass Stents for Open-Angle Glaucoma (OAG): 54-Month Outcomes (PO001)
- Robert D. Fechtner, MD – Long-Term Outcomes of a Prospective Study of Two Trabecular Micro-Bypass Stents vs. Prostaglandin in Newly Diagnosed OAG: Five-Year Follow-Up (PO002)
- Jason Bacharach, MD – Outcomes through 48 Months Following Standalone Implantation of Micro-Invasive Glaucoma Surgery (MIGS) with Two Trabecular Bypass Stents in Eyes with OAG Not Controlled on One Medication (PO004)
- Hady Saheb, MD MPH – Long-Term 48-Month Outcomes of Refractory Glaucoma Patients Treated with Two Trabecular Micro-Bypass Stents, One Suprachoroidal Stent and a Topical Prostaglandin (PO005)
- Steven D. Vold, MD – Treatment with Standalone Implantation of Two Trabecular Micro-Bypass Stents Combined with Topical Prostaglandin in OAG on Two Preoperative Medications: Four-Year Outcomes (PO007)
- Michael C. Stiles, MD – Single-Surgeon Experience with Trabecular Micro-Bypass Stent Implanted in Combination with Cataract Surgery in Eyes with Prior Medical and/or Surgical Glaucoma Therapy: Five-Year Outcomes (PO008)
- Savak Teymoorian, MD MBA– IOP and Medication Reduction after MIGS with Second-Generation Trabecular Bypass Stents in OAG Subjects on One Preoperative Medication: 30-Month Post-Op Outcomes (PO009)
- Anand V. Mantravadi, MD – MIGS with Two Second-Generation Trabecular Bypass Stents Combined with Topical Prostaglandin in Eyes with OAG on Two Preoperative Medications: 30-Month Outcomes (PO010)
- Paul Harasymowycz, MD – Evaluation of Second-Generation Trabecular Micro-Bypass Stents in Patients with Mild to Severe Glaucoma: A Canadian Study (PO011)
Friday, March 2, 2018
- Steven R. Sarkisian, Jr., MD – Interim Results of a Prospective, Randomized Phase II Study Evaluating the Safety and Efficacy of Travoprost Intraocular Implants: Three-Month Outcomes (PO071)
Glaukos will also sponsor an interactive lunch discussion for surgeons, entitled “Transforming Glaucoma Therapy with MIGS Technologies” on March 1, 2018 at 12:15-1:45 EST at the Marriott Marquis, 7th Floor, Soho Complex Room. Dr. Fechtner will moderate a panel that will include L. Jay Katz, MD; Richard A. Lewis, MD; and Thomas W. Samuelson, MD. Surgeons may register online at https://bmcg.regfox.com/glaukos-ny. In addition, Glaukos will be exhibiting throughout the meeting at Booth #8 on the showroom floor.
Glaukos pioneered MIGS and received U.S. Food & Drug Administration (FDA) approval for the industry’s first MIGS device, the iStent® Trabecular Micro-Bypass Stent, in 2012. Inserted through a small corneal incision made during cataract surgery, the iStent is designed to reduce IOP in mild-to-moderate OAG patients by restoring the natural physiological outflow of aqueous humor through the trabecular meshwork and into Schlemm’s canal, the eye’s primary drainage channel. Glaukos is currently pursuing FDA approvals for five additional MIGS surgical and sustained pharmaceutical therapy pipeline products:
1. iStent inject® Trabecular Micro-Bypass System, which is designed for use during cataract surgery and allows a surgeon to inject stents into two trabecular meshwork locations through a single corneal entry point. The iStent inject is approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South America.
2. iStent® SA Trabecular Micro-Bypass System, which is a standalone, two-stent procedure that is similar to the iStent inject and designed to reduce IOP in pseudophakic, mild-to-moderate OAG eyes.
3. iStent infiniteTM Trabecular Micro-Bypass System, which is a standalone, three-stent procedure, designed to reduce IOP in refractory OAG patients.
4. iStent Supra® Suprachoroidal Micro-Bypass Stent, which is designed to reduce IOP by accessing the eye’s suprachoroidal space and is approved in the European Union.
5. iDoseTM Travoprost, which is an implant containing a special formulation of travoprost, a prostaglandin analog used to reduce IOP. Implanted during a micro-invasive procedure, the iDose Travoprost is designed to continuously elute therapeutic levels of the medication from within the eye for extended periods of time. When depleted, it can be removed and replaced in a similar, subsequent procedure.
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 OAG 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, the ability of our products to achieve outcomes consistent with data provided in the poster presentations referenced in this release and our ability to secure U.S. FDA approval and market acceptance for our pipeline products. 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 September 30, 2017 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.