Glaukos – 2013 Fierce 15

Glaukos CEO Tom Burns

Based: Laguna Hills, CA
Founded: 2001
CEO: Tom Burns

The Scoop: Glaukos has already made history as the maker of the tiniest device ever approved by the FDA. Now, as the company convinces more and more patients and physicians of the benefits its iStent can have in treating glaucoma, the California devicemaker is working to lock up the submarket it founded and snag a bigger share of the $5 billion global glaucoma space.

What Makes It Fierce: The world of glaucoma surgery is oddly anachronistic. When drugs and laser procedures fail, surgeons generally have to choose between trabeculectomy or implanting a shunt, two invasive procedures with high-risk profiles. And that was the case for roughly 50 years, Glaukos CEO Tom Burns said, until iStent came around.

Glaukos' device is a tiny titanium tube--about 1 mm long--inserted into the eye after cataract surgery that reduces in-eye pressure by allowing for the drainage of fluids. For patients with glaucoma, those intraocular fluids can build up and damage the optic nerve, marring patients' vision. Because iStent creates a permanent opening in patients' trabecular meshwork, it has the potential to free them from ever taking glaucoma drugs again, Burns said. The device is about 8,000 times smaller than a shunt, he said, and it's implanted through a tiny needle inserted into a patient's cornea.

With last year's FDA approval, iStent is already being used on patients with glaucoma undergoing cataract surgery, and, thanks to the company's foresight, Glaukos was able to hit the ground running right away. While testing iStent, the company snagged a B2 designation from the FDA, allowing it to charge for implants during clinical trials. Thus, most of the nation's Medicare contractors knew about the device and its efficacy well before it won FDA approval, Burns said, and the company was able to secure 100% coverage in just 7 months thereafter.

"The launch has been exceedingly powerful," he said. "The value proposition that a surgeon offers an iStent patient is, 'I can implant this microstent during your cataract surgery and possibly provide sustained glaucoma treatment and reduce your dependence on medications; Medicare will pay for the procedure and device; and in clinical studies, the implantation of an iStent during cataract surgery has been demonstrated to be as safe as cataract surgery alone.'"

Glaukos' iStent is inserted into patients' trabecular meshwork to relieve intraocular pressure.--Courtesy of Glaukos

More often than not, patients jump at the opportunity, Burns said. As a result, Glaukos is more than 50% above its sales projection, and the company has been adding reps each month to keep up with demand, he said.

The device's market is sizable already: Roughly 3.3 million U.S. cataract surgeries are performed each year, and about 20% of those patients have glaucoma comorbidities, Burns said. But the company has its sights set on the world's 67 million glaucoma patients, regardless of their other ailments, and, through expanded indications and coverage, Burns said iStent can compete for a slice of the $5 billion spent treating the disease.

"We believe this implant and procedure will ultimately become a meaningful treatment alternative to drug therapy for patients at the earliest stages of glaucoma, whether the device is implanted alone or as part of a combined cataract procedure," he said.

Investors would seem to agree. Glaukos has hauled in $156 million in venture capital since its founding, in February pulling down a $30 million round headlined by VC giants OrbiMed, InterWest and Facebook ($FB) investor Meritech. That cash will support the ongoing commercialization of iStent and the development of two next-gen technologies: one that implants multiple stents for increased pressure relief and one that targets a different outflow pathway in the eye.

Glaukos is the first to cash in on the market for microinvasive glaucoma surgery, but it won't be the last. Competitors have raised venture cash and launched stateside studies with tiny eye stents of their own, but Burns figures iStent won't have any direct competition for four years, right around the time Glaukos expects to roll out a second-generation product.

What To Look For: Glaukos has been courted by most of the major ophthalmic device companies, Burns said, and the company is keeping its ears open. At the same time, Burns said he believes Glaukos' pipeline of devices is strong enough to command a high Wall Street valuation if the company went the IPO route. For now, however, Glaukos is focused on expanding iStent's adoption among the nation's cataract and glaucoma sufferers and plugging away on FDA-targeted studies for its in-development implants.

For more:
Special Reports: Top 10 device and diagnostic FDA approvals of 2012 - Glaukos' iStent | The Biggest Med Tech VC Investments of Q1
Glaukos snags $30M venture round for tiny eye stent
FDA OKs first glaucoma stent for cataract surgery

-- Damian Garde (email | Twitter)

Editor's note: An earlier version of this profile misquoted CEO Tom Burns. We regret the error.

Glaukos – 2013 Fierce 15