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 products will be included in various presentations at the 37th Congress of the European Society of Cataract and Refractive Surgeons (ESCRS), which begins Saturday, September 14, 2019 at the Paris Expo, Porte de Versailles in Paris, France.
Glaukos will sponsor a symposium entitled "Introducing iStent inject W: The Trabecular Micro-Bypass Stent for Cataract Surgeons" on September 14, at 6 pm (CEST) in Pavilion 7, Room South 3. Symposium faculty includes Thomas Samuelson, MD, a U.S. surgeon who will serve as moderator; Christophe Baudouin, MD, PhD from France; Kjell Gunnar Gundersen, MD from Norway; and Fritz Hengerer, MD from Germany. Glaukos will be exhibiting on the showroom floor throughout ESCRS at booth B105 and its products will be included in various physician presentations, including (all times CEST):
Sunday, September 15
Presented Poster Sessions Glaucoma I and Glaucoma II
Poster Village, Pod 3
- 10:20 am Sustained intraocular pressure (IOP) and medication reduction after Micro-Invasive Glaucoma Surgery (MIGS) with second-generation trabecular bypass stents in open-angle glaucoma (OAG): 48-month outcomes
Presenting Author: F. Aptel
- 10:35 am A budget-impact analysis of the iStent inject trabecular micro-bypass system vs trabeculectomy for the treatment of glaucoma from a German payer perspective
Presenting Authors: H. Falvey, A. Buchholz, P. Buchholz, S. Bluemle, C. Steeds
- 10:45 am A study on outcomes of second-generation iStent inject micro-bypass with cataract surgery
Presenting Authors: K. Suleiman, R. Bafiq, T. Ressiniotis
- 3:00 pm Clinical effectiveness and safety of phaco combined with iStent inject G1 and iStent inject G2 in glaucoma service
Presenting Authors: S. Pipis, G. Panos, A. Vergados
- 3:55 pm Safety and efficacy of iStent inject trabecular micro-bypass stents during phacoemulsification for OAG associated with cataract
Presenting Authors: D. Cela, E. Brasnu, P. Hamard, C. Baudouin, A. Labbe
- 4:00 pm Single-surgeon experience with iStent trabecular micro-bypass implanted in conjunction with cataract surgery: long-term outcomes
Author: M. Gallardo; Presenter: P. Singh
Free Paper Session Micro-Invasive Glaucoma Surgery
Free Paper Forum, Podium 4
- 2:00 pm IOP-lowering effect with the iStent inject in primary OAG eyes with or without history of previous ocular surgery
Presenting Authors: F. Rufer, M. Dabiri, B. Alokla, M. Matthai, D. Holland
- 2:06 pm Prospective randomized study evaluating one, two or three trabecular micro-bypass stents for OAG: five-year outcomes
Presenting Author: A. Carceller Guillamet
- 2:12 pm Personal experience with second-generation trabecular micro-bypass stents (iStent inject) in patients with glaucoma: four-year follow-up
Presenting Author: F. Hengerer
- 2:36 pm Outcomes with second-generation trabecular micro-bypass stents (iStent inject) combined with cataract surgery in patients with glaucoma: an Australian experience
Presenting Authors: C. Clement, A. Ioannidis, M. Shiu, D. Manning, F. Howes
- 2:42 pm Initial real-world experience with iStent inject trabecular micro-bypass stents in combination with cataract surgery
Presenting Author: E. Liang
- 3:30 pm Initial clinical results after implantation of second-generation trabecular micro-bypass stents (iStent inject) with cataract surgery
Presenting Author: K. Gundersen
- 3:36 pm My observations after almost 300 trabecular micro-bypass glaucoma surgeries with iStent inject over a period of five years
Presenting Author: T. Neuhann
- 3:42 pm Phacoemulsification with Stenttrabecular micro-bypass stents in complex and moderate to advanced glaucoma: three-year effectiveness and safety outcomes
Presenting Authors: G. Moussa, P. Pandey, J. Panthagani, M. Kutubi, I. Masood
Monday, September 16
Free Paper Session Glaucoma Management
Free Paper Forum, Podium 4
- 5:36 pm Outcomes of phacoemulsification combined with two iStent inject trabecular micro-bypass stents and endocyclophotocoagulation
Presenting Authors: A. Barata, M. Georgopoulos, G. Ratnarajan
- 5:48 pm A cost-utility analysis of the iStent inject trabecular micro-bypass system plus cataract surgery in patients with mild to moderate OAG in France
Presenting Authors: C. Schweitzer, A. Labbe, A. Mudd, K. Nieland, J. Kleintjens, G. Gicquel, H. Falvey
E-Posters (Viewable throughout ESCRS at terminals in the Poster Village)
- Budget impact analysis of the iStent inject implant for OAG treatment in Spain
Authors: J. Belda, K. Schargel, M. Teus, C. Lavin, M. Soler, M. Appierto
- Real-world experience with iStent inject second-generation trabecular micro-bypass combined with phacoemulsification: a Canadian study reporting one-year outcomes
Author: P. Harasymowycz
- One-year outcomes of trabecular micro-bypass stents with concomitant cataract surgery in primary angle closure glaucoma
Authors: A. Salimi, M. Abu-Nada, P. Harasymowycz
- Multi-iStent inject implantation (four stents) in OAG; a glimpse into the future
Authors: M. Economou, T. Arnljots
- Single U.S. surgeon's early experience with iStent inject trabecular micro-bypass stents implanted in conjunction with cataract surgery
Author: M. Gallardo
- Retrospective study of our first 48 cases with two second-generation trabecular micro-bypass stents
Authors: B. Gonzalez Ferrer, R. Cordero Ros, C. Lavin Dapena, A. Ramos Castrillo
- The iStent implantation in combination with SLT as an effective method of lowering IOP in patients with glaucoma
Authors: M. Hajduga, I. Filipecka, M. Hajduga, K. Posluszny-Rutkowska, L. Drzyzga, E. Mrukwa-Kominek
- Cataract surgery with iStent inject implantation in high-risk glaucoma and ocular hypertension: six-month results
Authors: Y. Leng, M. Lane, S. Dulku
- Prospective evaluation of iStent inject trabecular micro-bypass implantation combined with a topical prostaglandin: four-year outcomes
Author: J. Myers
- Reduction in IOP and glaucoma drops after standalone iStent inject in pseudophakic eyes: nine- to 12-month results
Authors: M. Pavel, A. Nagar, M. Nagar
- Initial outcomes with second-generation trabecular micro-bypass stents (iStent inject) implanted in conjunction with phacoemulsification: single U.S. surgeon's experience
Author: S. Sarkisian
- Pivotal study of second-generation trabecular micro-bypass stents (iStent inject)implanted in conjunction with cataract surgery: analysis by baseline IOP
Author: S. Sarkisian
- Evaluation of the iStent inject in pseudophakic eyes with OAG: preliminary results
Authors: V. Vohra, A. Adam, C. Dineen, B. Karri, I. Madgula
- Evaluation of outcomes for patients undergoing iStent inject trabecular micro-bypass for the treatment of ocular hypertension and glaucoma
Authors: S. Zormpas, A. Matsou, R. Petrarca, C. Panos
- iStent inject: tips and tricks (video)
Authors: A. Tatham, F. Ruefer
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. Glaukos received U.S. Food and Drug Administration (FDA) approval for its first-generation MIGS device, the iStent, in 2012Its 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 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 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 have 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 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. 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 continued efficacy and safety profile of our products, as well as the potential applications of our products as might be suggested in the surgeon presentations referenced above. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our Quarterly Report on Form 10-Q for the first quarter ended June 30, 2019. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.comor 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.
Director, Investor Relations, Corporate Development Strategy