Irvine-based Ivantis Inc., an 11-year-old ophthalmic device maker of eyelash-sized stents used to treat glaucoma, couldn’t pick a better time to bring its first product, Hydrus Microstent, to market in the U.S.
Fort Worth, Texas-based competitor Alcon, which is in the microinvasive glaucoma surgical sector (MIGS)—a fast-growing segment with extensive Orange County ties—caused shockwaves in the industry last week when it announced it was pulling the CyPass Micro-Stent from the market, citing a lack of efficacy.
The product failure of the unit of Swiss pharmaceutical company Novartis AG, which has local operations in Irvine and Lake Forest, had an immediate positive impact on others in the industry.
The stock of San Clemente-based Glaukos Inc. (NYSE: GKOS), a MIGS technology forerunner, rocketed more than 60% on the news to its highest price ever.
The firm, which went public in 2015, had a $2.4 billion market value as of last Friday.
Glaukos launched its first MIGS device, iStent, in the U.S. in 2012, and posted $159 million in sales last year. It now has other glaucoma-related products in the pipeline.
Ivantis has raised $132 million since its inception, and wants to have its first product, Hydrus Microstent, on the market by year-end after getting Food and Drug Administration approval last month.
It’s one of just a handful of firms to get the FDA’s nod for a MIGS device, along with Glaukos, Alcon and Allergan PLC, which gained approval in 2016 for the Xen gel stent, which was originally developed by Aliso Viejo-based AqueSys Inc.
The FDA approved Alcon’s CyPass Micro-Stent about two years ago. The company pulled the product based on new analysis of five-year post-surgery data.
It hopes to reintroduce the product in the future.
On the Horizon
Ivantis executives say they feel confident its products will stand the test of time.
The FDA approval is based on the Horizon Trial, which the ophthalmic device maker said is the largest minimally invasive glaucoma surgery study ever conducted. It studied 556 mild-to-moderate glaucoma patients undergoing cataract surgery.
MIGS devices are implantable stents designed to drain excess fluid from the eye to alleviate intraocular pressure. High pressure, caused by an imbalance in fluid production and drainage, damages the optic nerve and can cause glaucoma and permanent vision loss.
Ivantis’ product is designed to reestablish the patient’s natural fluid outflow.
“Ophthalmologists in the U.S. will certainly welcome the approval of a next-generation canal-based MIGS device,” said Dr. David Chang, clinical professor of ophthalmology at the University of California-San Francisco.
He said overall clinical data supporting Hydrus Microstent “is very encouraging in terms of both safety and two-year efficacy and sets a new bar for the treatment of mild to moderate glaucoma in cataract patients.”
Glaucoma is the world’s second-leading cause of blindness, affecting more than 80 million people around the world, according to industry estimates.
Drugs make up the lion’s share of the more than $5 billion global glaucoma market; conventional surgical technologies, such as filtration, surgery, laser and tube shunt, “have significant limitations”—ineffectiveness and/or risky procedures—according to a report by ophthalmic marketplace intelligence provider Market Scope.
MIGS-related sales are a growing segment of the treatment market, projected to reach $900 million by 2021, up from $100 million in 2016, according to Market Scope.
With FDA approval taken care of, Ivantis Chief Executive Dave Van Meter wants to maintain the momentum.
“Through the end of this year and into 2019, our singular focus as an organization is the execution of a world-class product launch in the U.S. market, which is by far the largest market for MIGS devices in the world,” he said.
He told the Business Journal the company has added 3,500 square feet at its headquarters at the Discovery Business Center office park to support near-term growth.
It employs 60, over half added in the last 90 days.
The company will move into a new 28,000-square-foot headquarters facility elsewhere in the Irvine Spectrum area next year, he said.
“This future facility will house roughly 100 employees across all functions, including a world-class training center to support our field team and clinicians.”
Van Meter said Ivantis has hired and trained a small initial team of seasoned ophthalmic device sales representatives to introduce the product in the U.S.
“We are in the process of a highly controlled, focused launch. For the remainder of this year, we intend to roll the product out to a select group of clinicians … [and] a broader launch will occur toward the end of the year.”
Van Meter said the company’s well-funded for the U.S. product launch, with backing from med-tech venture capital and private equity firms.
Its last funding deal was a $25 million Series C round last January.
New investors included Boston-based RA Capital Management LLC, which specializes in healthcare and life sciences investments, and France-based Mérieux Développement, plus several existing investors.
The deal was designed to help Ivantis operate through 2020.
Both Ivantis and Glaukos will be spending money on lawyers in addition to R&D and marketing for their respective glaucoma devices.
Glaukos sued Ivantis in April alleging its Microstent device infringes on Glaukos’ iStent. Ivantis disputes the allegations and has filed its own counterclaims.
A scheduling conference is set for Monday, Sept.17 at 10 a.m. before U.S. District Judge James Selna at the Ronald Reagan Federal Building in Santa Ana.