Multiple Surgeon Presentations to Include Glaukos Technologies at 2018 American Society of Cataract and Refractive Surgery

Clinical Trial Results and Personal Experience Data to be Discussed at American Medical Conference

SAN CLEMENTE, Calif.--()--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 included in various physician presentations at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held at the Walter E. Washington Convention Center in Washington, D.C. on April 14–17, 2018.

Key Presentation Topics by Day and Time (EDT):

ASCRS Paper Presentations

Saturday, April 14, 2018 – Location: Level 1, 144A

     

1.

   

Michael Stiles, MD 1:02-1:07pm

Five-Year Single-Site Outcomes of Trabecular Bypass Stent and Cataract Surgery in Eyes with Previous Medical and/or Surgical Glaucoma Therapy
 

2.

John P. Berdahl, MD 1:07-1:12pm

Clinical Evaluation of Trabecular Micro-Bypass Stent in Glaucoma with Cataract Extraction in Open-Angle Glaucoma: Five-Year Results
 

3.

Atul Bansal, MD 1:12-1:17pm

Comparison of Long-Term Outcome of Trabecular Micro-Bypass Stent with Phacoemulsification in Patients with Early Versus Advanced Open-Angle Glaucoma
 

4.

Mark Gallardo, MD 3:02-3:07pm

Intraocular Pressure Control and Reduced Medications Two Years after Ab Interno Trabecular Stent Implantation with Cataract Surgery in Patients with Primary Open-Angle Glaucoma
 

5.

Richard A. Lewis, MD 3:07-3:12pm

Long-Term Intraocular Pressure Control with One, Two or Three Trabecular Micro-Bypass Stents for Open-Angle Glaucoma: 54-Month Outcomes
 

6.

John A. Hovanesian, MD 3:12-3:17pm

Thirty-Month Outcomes of MIGS with Two Second-Generation Trabecular Bypass Stents and Topical Prostaglandin in Eyes with Open-Angle Glaucoma on Two Preoperative Medications
 

7.

Thomas W. Samuelson, MD 3:17-3:22pm

Second-Generation Trabecular Micro-Bypass Stents Implanted in Conjunction with Cataract Surgery: Prospective Randomized Study
 

Sunday, April 15, 2018 – Location: Level 1, 144B

8.

John P. Berdahl, MD 3:07-3:12pm

Three-Month Interim Results of a Prospective Randomized Phase 2 Study of the Safety and Efficacy of Travoprost Intraocular Implantation
 

Monday, April 16, 2018 – Location: Level 1, 149AB

9.

Eva I. Liang, MD 1:02-1:07pm

Evaluation of MIGS with Trabecular Micro-Bypass Stents during Cataract Surgery in One of Largest Cohorts of Single-Surgeon Reports
 

10.

Kerry D. Solomon, MD 1:07-1:12pm

Micro-Invasive Glaucoma Surgery with Two Trabecular Micro-Bypass Stents Combined with Topical Prostaglandin in Open-Angle Glaucoma on Two Preoperative Medications: Four-Year Outcomes
 

11.

Jason Bacharach, MD 1:12-1:17pm

Five-Year Results of a Prospective Study of Two Trabecular Micro-Bypass Stents Versus Prostaglandin in Newly Diagnosed Open-Angle Glaucoma
 

12.

Fritz H. Hengerer, MD 1:17-1:22pm

One-Year Outcomes of Implantation of Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma
 

13.

Paul J. Harasymowycz, MD 1:22-1:27pm

Evaluation of Second-Generation Trabecular Micro-Bypass Stents in Patients with Mild to Severe Glaucoma
 

14.

Richard L. Lindstrom, MD 1:27-1:32pm

Intraocular Pressure and Medication Reduction through 30 Months after MIGS with Second-Generation Trabecular Bypass Stents for Open Angle-Glaucoma on One Preoperative Medication
 

15.

Eric D. Donnenfeld, MD 1:32-1:37pm

Outcomes through 48 Months after MIGS with Two Trabecular Bypass Stents in Eyes with Open-Angle Glaucoma Not Controlled on One Medication
 

16.

Tanner Ferguson 1:37-1:42pm

Clinical Evaluation of a Trabecular Micro-Bypass Stent as a Sole Procedure in Pseudophakic Patients with Open-Angle Glaucoma: Three-Year Results
 

Tuesday, April 17, 2018 – Location: Level 1, 143C

17.

Brandon Baartman, MD 8:02-8:07am

Evaluation of a Trabecular Micro-Bypass Stent with Cataract Extraction in Severe Primary Open-Angle Glaucoma
 

18.

Russell Swan, MD 8:07-8:12am

Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in Pseudoexfoliation Glaucoma: Three-Year Results
 

EyeWorld/ASCRS Authorized Education (EDT):

The Transformation of MIGS: Coming Soon

When:       Sunday, April 15, 2018
Where: Walter E. Washington Convention Center, Hall C (Lower level)
Registration & Reception: 4:45-5:15pm
Program: 5:15-6:15pm
Moderator: Ike K. Ahmed, MD
Faculty: John Berdahl, MD
David F. Chang, MD
Mark Gallardo, MD
Registration:

Meetings.eyeworld.org/glaukos

 

The ASCRS Annual Meeting is among the largest gatherings of anterior segment physicians, medical personnel, and industry executives in the ophthalmic industry. Glaukos will be exhibiting at booth #2642 on the showroom floor.

All educational content of the ASCRS•ASOA Annual Meeting is planned by its program committee, and ASCRS•ASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.

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, which has been shown to lower intraocular pressure in adult patients with mild-to-moderate open-angle glaucoma undergoing cataract surgery. The company is also pursuing FDA approval 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 Africa.
  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 infiniteTrabecular 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. iDose 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.

Glaucoma is characterized by progressive, irreversible, and largely asymptomatic vision loss caused by optic nerve damage. There is no cure for the disease and reducing intraocular pressure is the only proven treatment. Based on analysis of population-based surveys, medical claims data, and other statistics, the company estimates that there are approximately 5.4 million people in the U.S. with primary open-angle glaucoma, the most common form of the disease.

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 post-operatively 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)

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 secure U.S. regulatory approval for our pipeline products, the extent to which our current and future products obtain market acceptance, and the continued efficacy of our products as might be suggested in the educational symposium and presentations at the ASCRS 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 2017 Annual Report on Form 10-K 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.

Contacts

For Glaukos Corporation
Media Contact:
Cassandra Dump
(619) 971-1887
Cassy@pascalecommunications.com
or
Investor Contact:
Chris Lewis
Director, Investor Relations, Corporate Development & Strategy
(949) 481-0510
clewis@glaukos.com

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