SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, announced today that its products will be featured in various presentations at the American Academy of Ophthalmology (AAO) Annual Meeting on October 27-30, 2018 at McCormick Place in Chicago, IL.
Glaukos is sponsoring an educational symposium for surgeons during AAO titled “Introducing iStent inject®: MIGS Transformed” on Saturday, October 27, 5:30-7:30pm CDT in the Grand Horizons Ballroom at the Marriott Marquis Chicago. The faculty includes Thomas Samuelson, MD (Moderator); Eric Donnenfeld, MD; John Hovanesian, MD; Frank Howes, MD; and Inder Paul Singh, MD. Go here to register. Glaukos will also be exhibiting on the showroom floor throughout AAO at booth #1345.
Additional surgeon paper and poster presentations during AAO include:
Key Paper Presentations:
Monday, October 29, 2:00-5:15pm CDT, Location: S404
3:39pm: Aqueous Angiographic Aqueous Humor Outflow Improvement after
Trabecular Bypass in Human Glaucoma Patients (PA057)
Presenting Author: Alex Huang, MD
3:51pm: A Prospective, Randomized Pivotal Study of Second-Generation
Trabecular Micro-Bypass Stents (iStent inject) Implanted in
Conjunction with Cataract Surgery (PA058)
Presenting Author: Thomas Samuelson, MD
4:15pm: Interim Results of a Prospective, Randomized Phase 2 Study
Evaluating the Safety and Efficacy of Novel Sustained-Release
Travoprost Intraocular Implants (PA060)
Presenting Author: John Berdahl, MD
Key Poster Presentations:
Sunday, October 28, 12:45-1:45pm CDT, Location: South Hall A
Poster authors will be available during time provided above. The posters below will be available for viewing during exhibit hours on October 27-28.
Long-term Outcomes of Refractory Glaucoma Patients Treated with Two
Trabecular Micro-Bypass Stents, One Suprachoroidal Stent and
Presenting Author: Jonathan Myers, MD
Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in
Pseudoexfoliation Glaucoma: Long-term Results (PO110)
Presenting Author: Brandon Baartman, MD
Trabecular Micro-Bypass as a Standalone Procedure for Patients with
Glaucoma: A Systematic Review and Meta-Analysis (PO111)
Presenting Author: Paul Healey, MBBS
Long-term Safety and Effectiveness of One, Two or Three Trabecular
Micro-Bypass Stents as Treatment for Open-angle Glaucoma (OAG):
54-month Outcomes (PO113)
Presenting Author: Lilit Voskanyan, MD
Treatment with Standalone Implantation of First-Generation Trabecular
Micro-Bypass Stents Combined with Topical Prostaglandin in OAG with
Two Preoperative Medications: Five-year Outcomes (PO115)
Presenting Author: Quang Nguyen, MD
Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in
Severe Primary OAG: Long-term Results (PO116)
Presenting Author: Russell Swan, MD
Micro-Invasive Glaucoma Surgery (MIGS) with Trabecular Micro-Bypass
Stent in African Americans with OAG (PO119)
Presenting Author: Jennifer Lira, MD
Monday, October 29, 12:25-1:45pm CDT, Location: South Hall A
Poster authors will be available during time provided above. The posters below will be available for viewing during exhibit hours on October 29-30.
Intermediate Outcomes of iStent® or iStent
inject in Combination with Phacoemulsification (PO389)
Presenting Author: Yogesh Patodia, MD
Long-term Outcomes of iStent Trabecular Micro-Bypass in
Combination with Phacoemulsification (PO390)
Presenting Author: Yogesh Patodia, MD
MIGS with Second-Generation Trabecular Micro-Bypass Stents Combined
with Topical Prostaglandin in Eyes with OAG on Two Preoperative
Medications: 42-month Outcomes (PO391)
Presenting Author: David Lubeck, MD
Long-term Outcomes of a Prospective Study of Two Trabecular
Micro-Bypass Stents Compared to Prostaglandin in Newly Diagnosed OAG:
Five-year Follow-up (PO395)
Presenting Author: Savak Teymoorian, MD
Glaukos pioneered MIGS, which involves insertion of a micro-scale device from within the eye's anterior chamber through a small corneal incision. Glaukos MIGS devices are designed to reduce IOP by restoring the natural outflow pathways for aqueous humor. In 2012, Glaukos received U.S. Food and Drug Administration (FDA) approval and launched its first MIGS device, the iStent Trabecular Micro-Bypass Stent.
The company’s second-generation MIGS device, the iStent inject Trabecular Micro-Bypass System, was approved by the FDA in June 2018. 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 also been approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa. Glaukos is also pursuing FDA approval for additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the United States.
About iStent inject Trabecular Micro-Bypass System (U.S.)
Indication for Use: The iStent inject Trabecular Micro-Bypass System Model G2-M-IS is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild-to-moderate primary open-angle glaucoma.
Contraindications: The iStent inject is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber angle, retrobulbar tumor, thyroid eye disease, or 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 congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.
MRI Information: The iStent inject is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.
Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents.
Adverse Events: Common postoperative adverse events reported in the randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%).
Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.
For more information, visit www.glaukos.com.
About iStent Trabecular Micro-Bypass Stent (U.S.)
Indication for Use: The iStent Trabecular Micro-Bypass Stent is indicated for use in conjunction with cataract surgery for the reduction of 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.
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies 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 inject, measuring 0.23 mm wide and 0.36 mm long, 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 limitation, the extent to which our products may obtain regulatory approval and market acceptance, and the continued efficacy of our products as might be suggested in the presentations at the AAO meeting. 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 June 30, 2018 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.