July 2012

 

GLAUCOMA

 

Breaking news

iStent approval hailed as "game changer"


by Jena Passut EyeWorld Staff Writer

   
The iStent Trabecular Micro-Bypass

The iStent Trabecular Micro-Bypass

iStent with an IOL The iStent positioned with an IOL Source (all): Glaukos Corp.

The U.S. FDA has approved the iStent Trabecular Micro-Bypass (Glaukos Corp., Laguna Hills, Calif.), the first-ever ab interno implant for the treatment of glaucoma, and surgeons are hailing the move as a "game changer."

"This is the biggest development within the 25 years I have been doing glaucoma surgery," said Reay Brown, M.D., clinical professor, Emory University, Atlanta, and EyeWorld glaucoma editor. "It changes the options we have for doing surgery. It brings a new way of controlling pressure. It offers the hope that we'll be able to resurrect the internal outflow system, and hopefully that will bring with it greater safety and sufficient efficacy."

The iStent is indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild to moderate open-angle glaucoma (OAG) who are currently being treated with ocular hypotensive medication. It is a 1 mm device made of titanium that is implanted directly into Schlemm's canal using an inserter and intraoperative gonioscopy.

"We've spent the last decade becoming the foundational leaders of this emerging new MIGS (micro-invasive glaucoma surgery) class, and the iStent will be our first entry in what we expect will be a complete portfolio of new technology that will serve the full range of open-angle glaucoma," Thomas W. Burns, president and CEO, director of Glaukos, told EyeWorld soon after the announcement. "The iStent implant is a safe and compelling new treatment option to significantly reduce IOP in OAG patients undergoing cataract surgery," added L. Jay Katz, M.D., director, Glaucoma Service, Wills Eye Institute, Philadelphia. "I am greatly encouraged by the introduction of this new MIGS procedural implant class and FDA approval of this innovative device."

Dr. Brown agreed that the approval means more opportunities for treating glaucoma in a much less invasive way.

"MIGS surgery will open the door for us," he said. "There's less risk involved, as opposed to combination surgery with trabeculectomy, which has been the standard."

Because the iStent is implanted ab interno, the procedure is conjunctival sparing and blebless and preserves future therapeutic and surgical options for glaucoma patients. Glaukos has enrolled more than 4,000 patients worldwide in clinical studies evaluating iStent devices in OAG.

Mr. Burns said he is excited for the small company, which has raised $126 million in capital over the years to create the market class. With that funding, Glaukos went for full pre-market approval for the iStent.

"We made that strategic decision very early to go for the full [pre-market approval] (and first and only controlled comorbidity trial for a glaucoma device) because I believed that this technology could serve patients at a far earlier stage of glaucoma," Mr. Burns said.

A 510(k) approval would have been far more limited to an end-stage glaucoma patient, Mr. Burns said. Mr. Burns said the company is rolling out the device by conducting a very methodical, controlled clinical launch with a select group of glaucoma specialists and comprehensive cataract surgeons.

"This will be a 3-6 month process, and then we will begin to open up the procedure to a far broader range of surgeons," he said. Mr. Burns added that Glaukos is conducting 18 concurrent prospective clinical trials around the world to validate the technology. "This is a whole new market class that will change the standard of care in glaucoma," he said. "We're not here to launch a product. We're here to advance patient care and to change hearts and minds. In that sense, we are pioneers." Iqbal "Ike" K. Ahmed, M.D., assistant professor of ophthalmology, University of Toronto, has been using the iStent for more than 3 years in Canada.

"Patients love it. They're very pleased, and the recovery is pretty much the same," he said. "Now we're able to treat two of the most common diseases we see. Up to 20% of our patients that we do cataracts on have glaucoma, ocular hypertension, or are on glaucoma medication. There's so much more we can do for our patients now without subjecting them to the complication profile that we have with trabeculectomy," he said "In my opinion, this is redefining glaucoma treatment. It has opened the door."

The device, Dr. Ahmed predicts, will create more glaucoma surgeons from those already performing cataract surgery.

"It's going to make them look at glaucoma treatment differently, and they will naturally gravitate toward it," he said.

Editors' note: Drs. Katz and Ahmed have financial interests with Glaukos. Dr. Brown has no financial interests related to this article.

Contact information

Ahmed: 416-625-3937, ike.ahmed@utoronto.ca
Brown: 404-237-4368, reaymary@comcast.net
Burns: tburns@glaukos.com

iStent approval hailed as "game changer" iStent approval hailed as "game changer"
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