Wired News – Glaukos Submits Pre-Market Approval Application to FDA For iStent Inject(R) Trabecular Micro-Bypass

LONDON, UK / ACCESSWIRE / December 29, 2017 / Active-Investors.com has just released a free research report on Glaukos Corp. (NYSE: GKOS). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=GKOS as the Company’s latest news hit the wire. On December 27, 2017, the Company declared that it has submitted a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for the iStent inject® Trabecular Micro-Bypass Stent. Register today and get access to over 1000 Free Research Reports by joining our site below: www.active-investors.com/registration-sg.

Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Glaukos most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below: www.active-investors.com/registration-sg/?symbol=GKOS.

iStent Inject Represents First of Five New Products to be Introduced Over Next Five Years

Commenting on the PMA application, Thomas Burns, President and Chief Executive Officer (CEO) of Glaukos, stated that the iStent inject represents the first in a series of five new products that the Company is expecting to introduce over the next five years, culminating in what it believes will be the industry’s broadest portfolio of technologies designed to address the full range of glaucoma disease states and progression.

About the iStent Inject

The iStent, a trabecular micro-bypass stent, is a Micro-Invasive Glaucoma Surgery (MIGS) device. The iStent inject is designed to improve the aqueous humor outflow into the Schlemm’s canal and reduce intraocular pressure (IOP) in mild-to-moderate open-angle glaucoma patients undergoing cataract surgery. Each iStent inject stent is approximately 0.23 mm x 0.36 mm, which the Company believes is the smallest medical device ever approved by the FDA.

Glaukos to Begin Randomized US IDE Pivotal Clinical Trial for the iStent SA™ System

On December 19, 2017, FDA allowed Glaukos to move forward with a US Investigational Device Exemption (IDE) pivotal study of its iStent SA™ Trabecular Micro-Bypass System. The iStent SA™ is intended for use as a standalone procedure for the reduction of IOP in pseudophakic, mild-to-moderate primary open-angle, pigmentary or pseudoexfoliative glaucoma patients.

Glaukos to Release Safety Data from Trial in First Half of 2018

The iStent inject prospective, randomized, multicenter clinical trial was conducted in 41 sites and included 505 randomized subjects who received either iStent inject in combination with cataract surgery, or cataract surgery alone. The iStent inject met its primary effectiveness endpoint in the trial, which was a 20% or greater reduction in IOP from baseline at 24 months. Glaukos plans to release efficacy and safety data from the trial sometime in the first half of 2018.

About iStent inject® Trabecular Micro-Bypass Stent

The iStent inject® 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. The iStent is contraindicated in eyes with primary or secondary angle closure glaucoma, and any other type of condition that may cause elevated episcleral venous pressure. The most common post-operative adverse events reported in the randomized pivotal trial included early post-operative corneal edema, posterior capsular opacification, stent obstruction, early post-operative anterior chamber cells, and early post-operative corneal abrasion.

About Glaucoma

Glaucoma is a group of eye diseases which, in most cases, produce increased pressure within the eye. This elevated pressure is caused by a backup of fluid in the eye. Over time, it causes damage to the optic nerve. Through early detection, diagnosis, and treatment, physicians can help to preserve patients’ vision. There is no cure for the disease and reducing IOP is the only proven treatment.

About Glaukos Corp.

Founded in 2001, 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 has pioneered Micro-Invasive Glaucoma Surgery (MIGS) to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos is headquartered in San Clemente, California.

Stock Performance Snapshot

December 28, 2017 – At Thursday’s closing bell, Glaukos’ stock slightly advanced 0.08%, ending the trading session at $26.05.

Volume traded for the day: 585.09 thousand shares.

After yesterday’s close, Glaukos’ market cap was at $904.46 million.

The stock is part of the Healthcare sector, categorized under the Medical Instruments & Supplies industry. This sector was up 0.2% at the end of the session.

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