Glaukos reports optimistic outlook for growth of MIGS
Increased domestic reimbursements plus reimbursement approvals abroad portend well for the company's 2017 outlook.
Glaukos is advancing several new MIGS devices through the regulatory process as it continues to expand its reach on several continents, Thomas Burns, Glaukos president and CEO, told investors at the 35th Annual J.P. Morgan Healthcare Conference in San Francisco.
“Over the past 15 years, we’ve been dedicated to creating an entirely new market space within ophthalmology called MIGS, microincisional glaucoma surgery,” Burns said. “And in the process of doing that, we’ve developed a series of microstents which will be able to treat glaucoma from its most incipient stages of naïve patients to the most advanced stages of refractory glaucoma.”
The 1 mm long iStent was approved by the FDA in 2012 for implantation in conjunction with cataract surgery and is covered by Medicare. Since U.S. commercialization in June 2012, Glaukos has seen 13 consecutive quarters of greater than 40% year-on-year growth, Burns said.
In addition, CMS upgraded payment for code 0191T “from payment of $1,794 for the facility up to $2,538 for this next year,” Burns said. “You’ll see that translate into 2017, which in addition to our unit growth gives us tremendous opportunity for additional robust growth as we go forward.”
Glaucoma represents a $5 billion marketplace worldwide, Burns said, and Glaukos is advancing its presence across the globe.
“Today I announce that we’ve successfully ... secured reimbursement approval from the Japanese,” he said. Although the company is still “U.S.-centric,” Burns said the company is opening markets globally, citing progress in Germany, Australia, Canada and Brazil.
In the pipeline
In the pipeline is what Burns called “the next generation” of iStent, or iStent inject, a preloaded needle that injects two stents, for which Glaukos has completed a phase 1 clinical trial.
In a Glaukos study involving patients unresponsive to two glaucoma medications, patients were randomized to receive one, two or three stents, Burns said.
“With each additional stent, we’re getting an incremental decrease in intraocular pressure and validating the fact that two stents is going to be, I think, a real winner in the marketplace and maybe three stents in the future,” Burns said.
The iStent Supra is another up-and-coming product that Burns said is in the late stages of an investigational device exemption clinical trial.
He explained that the device is meant to treat patients with severe glaucoma and works in the suprachoroidal space, which is highly vascular. Burns said the procedure can cause more collateral damage, bleeding and hypotony.
“Having said that, we think invariably it’s important to place this product in combination with iStent for patients who are more progressive or moving to more advanced glaucoma,” he said.
Glaukos is also working on iDose, an extended drug delivery platform that Burns said could have a large impact on glaucoma treatment.
“We’ve got a lot to prove, but we’re in a current phase 2b clinical trial here in the States, and I expect to have data available by the end of the year,” he said. – by Joe Green
- Burns T. Glaukos Corporation. Presented at: J.P. Morgan Healthcare Conference; Jan. 11, 2017; San Francisco.
Disclosure: Burns reports he is president and CEO of Glaukos.