Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today that its technologies will be featured in various “on demand” presentations at the American Society of Cataract and Refractive Surgery (ASCRS) Virtual Annual Meeting, which will be held online on May 16-17, 2020.
KEY GLAUCOMA PRESENTATIONS:
Brandon J. Baartman, MD
Ocular Surface Disease Improvement in Eyes Implanted with Trabecular Meshwork Bypass Stents (iStent® or iStent inject®)
John P. Berdahl, MD
Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in Open-Angle Glaucoma: Seven-Year Results
Beau J. Billings
Early Results of Second-Generation Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgery in a Real-World Setting
Beau J. Billings
Outcomes of iStent Implantation with Femtosecond Laser-Assisted Cataract Surgery versus Manual Cataract Surgery
Tanner J. Ferguson, MD
Second-Generation Trabecular Micro-Bypass Stent Implantation with Cataract Surgery: Early Clinical Experience
Tanner J. Ferguson, MD
Trabecular Micro-Bypass Stent Implantation with Cataract Extraction in Pseudoexfoliative Glaucoma: Six-Year Results
Mark J. Gallardo, MD
Second-Generation Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgery in Open-Angle Glaucoma: Single-Surgeon Outcomes
Richard A. Lehrer, MD, ABO
Long-Term Outcomes of Trabecular Bypass Stenting with Cataract Surgery Including VF, OCT and Disease Progression: Real-World Case Series
Eva I. Liang, MD
Early U.S. Experience with the Second-Generation Trabecular Micro-Bypass Stents in Combination with Cataract Surgery
Richard L. Lindstrom, MD
Sustained Five-Year Safety and IOP Outcomes in Open-Angle Glaucoma Subjects Treated with Trabecular Micro-Bypass Stents (iStent inject)
David K. Manning, MD
Two-Year Outcomes of Second-Generation Trabecular Micro-Bypass Stents (iStent inject) Combined with Cataract Surgery
Ali Salimi, MSc
Second-Generation Trabecular Micro-Bypass Stents (iStent inject) with Cataract Surgery in Normal Tension Glaucoma: One-Year Outcomes
Thomas W. Samuelson, MD
Long-Term Safety and Patient Reported Outcomes on Second-Generation Trabecular Micro-Bypass Stent System
Steven R. Sarkisian Jr., MD
Real-World U.S. Experience with Second-Generation Trabecular Micro-Bypass Stents (iStent inject) Implanted in Conjunction with Cataract Surgery
Keith Walter, MD, ABO
Case Series of Trabecular Micro-Bypass Stents Implanted Inferiorly in Combination with Cataract Surgery
George R. Wandling Jr., MD
Early Outcomes from a Real-World Study of Second-Generation Trabecular Micro-Bypass Stents (iStent inject) Combined with Cataract Surgery
Blake K. Williamson, MD
Early U.S. Experience with iStent inject Trabecular Micro-Bypass Implantation with Cataract Surgery
KEY CORNEAL HEALTH PRESENTATIONS:
Miltiadis Balidis, PhD
Transepithelial Customized Corneal Collagen Cross-Linking for Keratoconus
Chunlei Liu, MD, PhD
Comparison of One-Year Outcomes between SMILE Xtra and LASIK Xtra
Julianne M. Matthews, MD, MPH
How Long Does It Take for BCVA, Kmax, and Pachymetry to Return to Baseline after Corneal Collagen Cross-Linking for Keratoconus?
Angelica Ortiz, MD
Corneal Cross-Linking in Keratoconus Patients: One-Year Visual and Keratometric Outcomes
Shreyas Ramamurthy, MD
Comparative Study of Conventional Epithelium-Off Cross-Linking (CXL) versus High Fluence Transepithelial CXL with Supplemental Oxygen
Borja Salvador-Culla, MD
Continuous versus Pulsed Accelerated Cornea Cross-Linking to Arrest Progression of Corneal Ectasia: A Multicenter Study
Gina Shetty, MD
Corneal Cross-Linking (CXL) Outcomes in Children with Progressive Keratoconus
Dian Yu, MD
Early Evidence of Visual and Topographic Improvements Following Cross-Linking Procedure for Eyes with Keratoconus
Abstracts and full session details can be found at www.ascrs.org.
The ASCRS Annual Meeting is among the largest gatherings of anterior segment physicians, medical personnel and industry executives in the ophthalmic industry. All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve or recommend the use of any products, devices or services.
Glaukos pioneered Micro-Invasive Glaucoma Surgery (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. Glaukos received U.S. Food and Drug Administration (FDA) approval for its first-generation MIGS device, the iStent, in 2012. Its second-generation iStent inject, which received FDA approval in 2018, includes two stents preloaded in an auto-injection mechanism that facilitates stent insertion into multiple trabecular meshwork locations through a single corneal incision. The iStent inject is also approved in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, South Africa and other international markets. Glaukos is 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 (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 Photrexa® Viscous and Photrexa
Indications: Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL® System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
Important Safety Information: Corneal collagen cross-linking should not be performed on pregnant women. Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects. The most common ocular adverse reaction was corneal opacity (haze). Other ocular side effects include punctate keratitis, corneal striae, dry eye, corneal epithelium defect, eye pain, light sensitivity, reduced visual acuity and blurred vision. These are not all of the side effects of the corneal collagen cross-linking treatment.
For more information, go to www.livingwithkeratoconus.com/ to obtain the FDA-approved product labeling.
Photrexa Viscous and Photrexa are manufactured for Avedro. The KXL System is manufactured by Avedro. Avedro is a wholly owned subsidiary of Glaukos Corporation.
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. 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 launched its next-generation iStent inject device in the United States in September 2018. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.
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 and safety profile of our products as might be suggested in the presentations at the ASCRS meeting. These risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission on May 7, 2020. 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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