Glaukos Corp. is in the process of an expanded roll out for what it says is a game-changing device.
The product, the iDose TR, is said to be the first long-term sustained release pharmaceutical for the treatment of glaucoma, according to the Aliso Viejo-based medical technology company.
“It was born of a 15-year odyssey,” Glaukos Chief Executive Thomas Burns told the Business Journal. “The development was Herculean.”
Glaukos launched the iDose TR last year after gaining approval in 2023 and is now working on securing reimbursement for the product, which has been a challenge due to recent local coverage determinations (LCD) restrictions.
The medtech company, which has spent nearly $1 billion on research, is positioning itself to use the iDose technology to treat other eye-related problems like dry eyes, keratoconus and presbyopia. If successful, the treatments could eliminate the use of eye drops, which are considered an ineffective way to deliver medication inside the eye.
The company has 14 publicly disclosed other products in its pipeline, including a second-generation iDose dubbed iDose Trex that’s being put through clinical trials.
Glaukos also received Food and Drug Administration acceptance for review of its New Drug Application (NDA) for Epioxa, an eye therapy made to stop the progression of keratoconus. Burns said that an FDA approval decision for Epioxa is expected by the end of this year.
Founded in 1998, Glaukos is the maker of the world’s smallest medical device.
Its flagship product, iStent, is a microscopic implantable device that reduces intraocular pressure in the eye.
The company on June 25 celebrated the 10th anniversary of its initial public offering listing by participating in the NYSE closing bell ceremony. Since its IPO went public at $18 each, the shares have risen more than fivefold to $99.74.
Glaukos is currently the most valuable public company in Orange County’s thriving ophthalmology sector with a market cap of $5.7 billion (NYSE: GKOS).
Bolstering R&D Efforts
Burns said that if the company were to stop innovating today that it would have enough products to bring into the mid-2030s.
Over 30% of revenue has been reinvested in research and development since he took over as CEO in 2002, equating to nearly $1 billion, according to Burns.
To support these efforts, Glaukos is building a 200,000-square-foot R&D manufacturing facility in Huntsville, Alabama. Glaukos is spending $82 million on the facility, with construction set to begin in September, Burns said. Once complete, it’s expected to create 164 full-time jobs in the region by 2030.
The company is also expanding locally.
In April, Glaukos purchased a two-floor, 40,000-square-foot building next to its headquarters for $16.6 million.
Burns didn’t disclose the company’s intentions for the site but called it a “necessary acquisition.”
“We’re growing at such a fast pace that we’ll need it in short order,” he said. “We’re trying to create a full campus here—that’s part of the reason that we need it.”
Paving Pathway for Reimbursement
“If you saw us 20 years ago, you would have been utterly unimpressed,” Burns said.
The company used to reside in a 5,000-square-foot facility “with soiled carpets and a boardroom table that looked like something you wouldn’t put in your startup,” he said.
Then, before the company gained FDA approval for iDose, it took a risk and built a $100 million plant in San Clemente, which opened in 2016. Glaukos now has nearly 400,000 square feet of manufacturing space in Aliso Viejo and San Clemente.
“That’s where some of the audacity, call it calculated risk, comes in, and it has paid off handsomely,” Burns said.
Glaukos further took a risk by spending a decade on clinical trials for iDose TR.
At the time, Burns said there were concerns on how the product would make its way into the eye and how they could make a compound that was more potent than topical eyedrops.
“There’s probably a lot more reasons why this shouldn’t have succeeded than why it did,” he said.
One of the current biggest challenges with iDose TR is paving the pathway for reimbursement, Burns said.
Beginning in the fourth quarter of 2024, Medicare Administrative Contractors began implementing restrictions limiting the use of multiple surgical devices in the same procedure.
“These challenges are not unique. They exist within every new product, especially in a new marketplace,” Burns said. “Eventually we’re going to get there.”
The reimbursement issue was a key reason for share volatility. Based on surveys of doctors, investors became so excited about the potential of Glaukos that they more than doubled the price from late 2023 until early February to more than $160 each. The shares subsequently fell in half when it became clear that getting reimbursements through the complicated bureaucracy of Medicare would take much longer than investors expected.
Glaukos’ iDose TR, which lasts up to three years, has also had coverage limited to one implant but is appealing the matter with the FDA and expects to get an answer by the end of the year.
Sees Future in Retinal Space
Glaukos’ newest focus with Epioxa is targeting what Burns describes as a misunderstood and misdiagnosed disease.
Keratoconus is a progressive eye disease where the cornea thins and develops into a cone-like shape, distorting vision.
The disease occurs in kids in their late teens with 20% of patients needing a corneal transplant, according to Burns.
Traditionally, keratoconus is treated by having the outermost layer of the eye removed with a blade.
Instead, Epioxa is surgery-free and topically administered.
“With a single procedure, we’re able to shut down the progression of this disease,” he said.
Burns says that he eventually sees Glaukos as a player in the retinal space.
He said that the company is developing an implant to go in the back of the eye that could last up to several months.
“This is an over $20 billion marketplace, and if we’re successful, we might be a player in retinal disease as well,” Burns said.
Better-Than-Expected Q1 Results
Analysts have expressed optimism in the company’s legacy products, as well as those upcoming.
“We also see GKOS as an attractive strategic asset with a broader pipeline that’s not getting enough credit from the Street,” Piper Sandler analysts Adam Maeder and Kyle Winborne wrote in a June 13 note to investors.
Shares in Glaukos are up nearly 20% since it reported better-than-expected first quarter results on April 30.
The company had another record quarter, reporting that revenue increased 25% to $106.7 million, surpassing the consensus estimate of $102.5 million.
This growth was driven largely by growing contributions from iDose TR, according to the company.
Glaukos maintained its full year revenue guidance of $475 million to $485 million, which at the midpoint implies 25% growth.
The company factored in issues such as the recent LCD restrictions when leaving guidance unchanged, said Joe Gilliam, president and chief operating officer of Glaukos, during the company’s earnings call.
“While some parts of the business may see transient headwinds this year, the outlook here looks robust on many fronts,” Maeder, Winborne and Phillip Dantoin said in an April 30 analyst report.
“There’s no change to our view that there is upside to numbers this year behind iDose and this product represents a significant opportunity for the company longer-term.”
Piper Sandler estimated that iDose delivered about $21 million in sales, calling it a “strong iDose quarter.” The research firm reiterated its overweight rating and $165 price target for Glaukos.
Glaukos Receives EU Certification for iStent infinite, More Technologies
Glaukos Corp. is growing its presence in Europe with its latest approvals.
Last week, the company received European Union Medical Device Regulation certification for iStent infinite, along with several other micro-invasive glaucoma surgery (MIGS) technologies such as iStent inject W.
The milestone marks the first approval for the company under the new EU regulatory framework for medical devices and diagnostics.
“These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional Glaucoma initiatives globally,” Chief Executive Thomas Burns said in a statement.
“We are eager to commence commercial launch activities for these novel MIGS therapies over the coming months.”
The iStent infinite is an implant designed to reduce intraocular pressure in the eye. It’s indicated for us in adult patients with primary open-angle glaucoma who haven’t had success with other medical or surgical interventions.
More than one million iStent devices have been implanted worldwide since inception, according to the company.
