Ophthalmic technology specialist Glaukos Corp. has completed patient enrollment in the pivotal phase of its investigational device exemption trial for the Istent Supra Suprachoroidal Micro-Bypass Stent. The San Clemente, Calif.-based company's clinical trial includes 36 sites and 505 subjects with mild-to-moderate primary open-angle glaucoma and cataracts.

Subjects were randomized to receive either Istent Supra in combination with cataract surgery or cataract surgery alone. The study has a 24-month primary outcome measure of a 20 percent or greater reduction in intraocular pressure (IOP) from baseline.

The Istent Supra is designed to reduce IOP by accessing the suprachoroidal space in the eye. Also known as the unconventional pathway, this area is responsible for about 20 percent of aqueous fluid outflow. The stent is about 4 millimeters in length and curved to follow the eye's anatomy. The company received CE mark for the device in 2012.

"Our view continues to gain traction among surgeons that the highest efficacy and lowest risk is achieved by restoring conventional outflow first with trabecular bypass stents and that a suprachoroidal stent maybe appropriate adjunctive therapy for patients with more progressive glaucoma," said Thomas Burns, Glaukos' president and CEO, during the company's most recent earnings call.

The company is also working on bringing its Idose microscale implant to the market. The device is designed to be injected through a corneal incision and secured in the anterior chamber where it continuously elutes therapeutic levels of a special formulation of Travoprost for extended periods of time. When depleted, the company said that Idose can be removed and replaced providing potentially years of continuous IOP lowering therapy.

At one point Glaukos was the largest of the six players in the Micro-Invasive Glaucoma Surgery (MIGS) space. The company was the first to go public, beating expectations by bringing in $108 million in an initial public offering. Glaukos was also the first MIGS company to bring its product onto the market by receiving FDA approval about five years ago.

Glaukos' Istent accesses the eye's conventional pathway for aqueous humor outflow, which is through the trabecular meshwork and into Schlemm's canal.

The market has changed since Glaukos was founded in 1998. Most of the changes are due to a number of mergers and acquisitions in the MIGS space.

"We are confident in our competitive position; we're well prepared, and we're ready for other players to enter the marketplace," said Burns during the company's most recently reported earnings call.

Perhaps the greatest source of competition comes from Novartis AG. The Basel, Switzerland-based company acquired Transcend Medical Inc. and folded it into its Alcon division last year. (See Medical Device Daily, Feb. 19, 2016.) Novartis' Alcon received FDA approval in August of last year for Transcend's Cypass stent based off data from the COMPASS study.

Chris Lewis, an analyst with Roth Capital Partners, said Alcon's sales presence, customer base and physician relationships, could ultimately have some negative impact to Glaukos' growth profile.

He added "[However], the underlying MIGS market growth and accelerating adoption could likely offset any competitive headwinds [for Glaukos]."

Allergan plc, which made a $2.48 billion bid to acquire Zeltiq Aesthetics Inc. earlier this week, led the flurry of MIGS acquisitions when it acquired Aquesys Inc. for $300 million in an all cash transaction back in 2015. (See Medical Device Daily, Sept. 8, 2015.)

Osaka, Japan-based Santen Pharmaceutical Co. Ltd. quickly followed suit and scooped up Miami-based Innfocus Inc. for about $225 million. (See Medical Device Daily, July 20, 2016.)

Outside of Glaukos, Irvine, Calif.-based Ivantis Inc. and Wavre, Belgium-based Istar Medical SA are the only companies in the MIGS space that have not been picked up by a larger firm.