Shares of Aliso Viejo-based Glaukos Corp. soared 25% on Dec. 14 to a market cap approaching $4 billion (NYSE: GKOS), after the maker of devices and drugs to treat glaucoma got a big regulatory win.
The Food and Drug Administration okayed the company’s iDose TR, an ocular implant designed to treat open-angle glaucoma and ocular hypertension.
“The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago,” Glaukos Chairman and Chief Executive Tom Burns said in a statement.
“We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension.”
Glaukos on Dec. 14 also reaffirmed its 2023 forecast and estimated revenue next year will rise 13% to 17% to $350 million to $360 million, which topped analysts’ consensus estimate.
iDose
Glaukos, founded in 1998, pioneered the now well-established microinvasive glaucoma surgery (MIGS) marketplace. Its best-known product is the iStent, which is among the smallest medical devices ever made.
About 15 years ago, Burns asked his scientists if they could invent a device like iStent to deliver medication.
Research shows 90% of patients are non-compliant with topical medication use and 50% purposely discontinue their medication within six months. Worse, only about 7% of eyedrops actually reach the affected area, “There’s a high rate of non-compliance — it’s a complex dosage,” Glaukos Chief Development Officer Tomas Navratil told the Business Journal. “These topical eyedrops have host of disadvantages.”
Glaukos began a decade of clinical trials in 2012. The FDA approval last month came after the company completed two prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials involving 1,150 subjects across 89 clinical sites.
80M Sufferers
About 80 million patients worldwide suffer from glaucoma, with five million having lost their vision, Navratil said.
“That’s like the entire nation of Ireland,” said Navratil. “We have a chance to really change the standard of care.”
Doctors implant the iDose, which is made from medical-grade titanium and is about half-a-millimeter wide and 1.8 millimeters long. Once implanted, 75 micrograms of a proprietary formulation called travoprost continuously elutes into the anterior chamber via membrane-controlled diffusion.
Hence, instead of a typical 2,190 eye drops administered per eye during a three-year period, a patient only needs to receive “one administration” of iDose that is secreted into the affected area 24/7 for three years. Travoprost is 25,000 times more concentrated than a typical glaucoma medication, Navratil said.
Glaukos on Dec. 14 disclosed a meaningful, higher-than-expected average selling price of $13,950, which was “the key positive,” Jefferies analyst Michael Sarcone wrote in a note to investors.
The high price point is because iDose is cheaper in the longer run than other medications to treat glaucoma, Navratil said.
“If you look at the class of procedural pharmaceuticals, iDose is the most cost effective.”
Glaukos said that for every iDose sold, it will make available an equal number of iDose units for qualifying charitable donation requests around the globe.
The company plans to train surgeons in the first half this year, receive procurement codes from Medicare and then accelerate its marketing.
“We expect to be at full speed by the end of year,” Navratil said. “We know how to do it well and we’re following our successful blueprint for iStent, our first product.”
