OREANDA-NEWS. 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 clinical data regarding its products will be presented in 12 Key Opinion Leader (KOL) podium and poster presentations at the annual Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Copenhagen, Denmark on September 10 – 14, 2016.

Presentation Topics by Day and Time (Central European Time, CET):

Sunday, September 11, 2016
      1.  

3:06pm – 3:12pm Fritz Hengerer, MD - Personal experience and outcomes through one year following implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma
         

Location: Auditorium C6, Free Paper Session

Monday, September 12, 2016
     

2.

  

8:00am – 8:06am Antonio Fea, MD – Reduced IOP and medication burden through 30 months: prospective, randomized, comparative study in OAG patients of implantation of 1, 2 or 3 trabecular micro-bypass stents as a sole procedure
         

Location: Hall C4, Glaucoma II
     

3.

  

9:38am– 9:44am M. Braun, MD – Comparison of the IOP lowering effect of cataract surgery in combination with microinvasive glaucoma surgery (MIGS)
         

Location: Hall C4, Glaucoma II

Tuesday, September 13, 2016
     

4.

  

2:00pm – 2:06pm Tobias Neuhann, MD – Continued long-term results after implantation of a single trabecular bypass stent during small incision cataract surgery in patients with glaucoma or ocular hypertension
         

Location: Auditorium C6

Poster Abstracts
      5.  

Gerd Auffarth, MD – Three-year outcomes from prospective, randomized study of micro-invasive glaucoma surgery (MIGS) with two trabecular stents vs one prostaglandin in newly diagnosed open-angle glaucoma
      6.  

Milena Kozera, MD – Mid-term assessment of findings following implantation of a trabecular micro-bypass stent and cataract surgery via phacoemulsification in patients with mild-moderate open-angle glaucoma and cataract
      7.  

A. Nagar, MD – Intraocular pressure reduction after combined phacoemulsification and iStent implantation
      8.  

Konrad Schargel, MD – Analysis of refractive changes in patients with phacoemulsification plus iStent vs phacoemulsification
      9.  

Jose Belda, MD – Eighteen-month postoperative outcomes following implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma not controlled by one preoperative medication
      10.  

Johannes Gonnermann, MD – Contralateral eye comparison study in MICS and MIGS: Trabectome® vs iStent inject® (one-year results)
      11.  

Anselm J?nemann, MD – Second generation trabecular micro-bypass stents and one postoperative prostaglandin in patients with open-angle glaucoma not controlled with two preoperative medications
      12.  

Matthias Klamann, MD – iStent inject as stand-alone procedure in phakic open angle glaucoma: first clinical annual results

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® Trabecular Micro-Bypass Stent, which has been shown to lower intraocular pressure (IOP) in adult patients with mild-to-moderate open-angle glaucoma undergoing cataract surgery.

The company’s next-generation MIGS device, the iStent inject® Trabecular Micro-Bypass Stent includes two stents preloaded in an auto-injection mechanism that allows an ophthalmic surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point. The iStent inject has been approved in the European Union, Australia and Canada. Glaukos has U.S. IDE clinical trials underway for two versions of the iStent inject, one for use in conjunction with cataract surgery and another for use as a standalone procedure. Glaukos has also developed the iStent Supra® Suprachoroidal Micro-Bypass Stent, which is designed to reduce intraocular pressure by accessing the suprachoroidal space in the eye. Approved in the European Union, the iStent Supra is also being evaluated in a U.S. IDE clinical trial.

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 Glaukos Corporation

Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures 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, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA.