Laguna Hills-based eye device maker Glaukos Corp. is ready to rev up marketing for its microscopic glaucoma treatment now that the Food and Drug Administration has granted approval for U.S. sales for the device.
Regulators recently approved Glaukos’ lead device, the iStent. The device is a 1-millimeter implant that’s placed in the eye and diminishes pressure by relieving fluid buildup; its width is slightly larger than a human hair.
“We were elated with the announcement of FDA approval—it’s a culmination of a decade of intensive research and development and extensive clinical studies to validate our technology,” Chief Executive Tom Burns said.
Glaukos now has the personnel and resources necessary to create “what I hope will be an enduring new market class in glaucoma and a legacy commercial launch in ophthalmology,” he said.
The company makes tiny devices implanted in the eye to treat glaucoma, which can’t be prevented but can have its progress stopped with treatment.
The iStent “will substantially raise the standard of care for the treatment of glaucoma,” Burns said.
Glaukos is privately held and does not disclose financial information.
It now is going after a big market with its device.
Glaucoma affects some 65 million people globally. Analysts have pegged the yearly drug and surgery market for treating the disease at around $4.5 billion.
Glaukos is part of a cluster of companies with OC operations for devices or drugs to treat glaucoma, a lineup that includes big names such as Allergan Inc. in Irvine; Switzerland-based Alcon Inc., which has about 1,100 employees in Irvine; and Abbott Medical Optics, the Santa Ana-based unit of Abbott Laboratories in Abbott Park, Illinois. Smaller companies working on glaucoma here include Ivantis Inc. and AqueSys Inc., both in Irvine.
Founded in 2001
Glaukos started in 2001 and now has more than 60 workers. Many of the company’s employees come from established drug and device makers in Orange County, including Allergan, Abbott Medical, and Edwards Lifesciences Corp. in Irvine.
Glaukos has been in the process of hiring a sales force over the past year or so in preparation for iStent’s full launch. Training will begin this week, Burns said.
“We’ve been on the verge of FDA approval for some time,” Burns said.
Glaukos is targeting ophthalmic surgeons for iStent, including surgeons who specialize in glaucoma surgery and other comprehensive ophthalmic surgeons, he said.
IStent’s manufacturing will involve outside contractors as well as Glaukos’ headquarters in Laguna Hills.
The 11-year old device maker has raised some $126 million in its history and has another round of equity financing in the works to help pay for the iStent’s introduction, Burns said.
Investors include Menlo Park-based Versant Venture Management LLC, which has an office in Newport Beach; Domain Associates LLC in San Diego; and Palo Alto-based Meritech Capital Partners.
Exit Strategy
The company is considering options on an exit strategy, including an initial public offering, and is talking with potential strategic partners attracted to Glaukos’ technology, Burns said.
Glaukos has worked to prepare itself for Medicare reimbursement. It received an FDA designation that allowed for reimbursements from Medicare when it first started its clinical trials for the iStent.
The intent was to allow the Centers for Medicare & Medicaid Services to review reimbursement well ahead of iStent’s launch, according to Burns.
Glaukos expects the early communication with Medicare will lead to broad reimbursement coverage, he said.
The company also has a pair of other products in development. One is an implant that is six times smaller than iStent and can’t be seen with the naked eye. That product is in registration with the FDA for an investigational device exemption.
A third product is a 4-millimeter tube that goes into the super choroidal space, which is located inside the eye’s anterior chamber.
