Glaukos Corp. got some good news on Sept. 7 when it revealed positive Phase 3 results for its new eye treatment called iDose TR.
Investors sent the company’s shares (NYSE: GKOS) up 21% in the two following trading sessions.
The results show “we can do a successful commercial launch” of iDose TR, Chief Executive and Chairman Thomas Burns told the Wells Fargo 2022 healthcare conference after the announcement was made.
He predicted full approval from the Food and Drug Administration by the end of 2023.
It’s a much-needed win for Glaukos, which saw its stock fall by more than half to as low as $33.33 last year when the Centers for Medicare and Medicaid Services reduced fees for the company’s current products.
Since then, the shares have rebounded to around $56 as of press time.
Glaukos, founded in 1998, is an ophthalmic company focused on devices and drugs to treat glaucoma, corneal disorders and retinal diseases. It 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.
The company, which recently moved its headquarters from San Clemente to Aliso Viejo, in September revealed 1 million iStents have been implanted worldwide since its introduction about a decade ago.
Before the introduction of iStent and MIGS, glaucoma treatment was limited to eyedrops or invasive surgery that carried more risk than needed for mild-to-moderate glaucoma. The iStent filled that gap between eyedrops and invasive surgery.
The iDose drug delivery system is a targeted injectable implant based on Glaukos’ microscale device-platform that is designed to continuously deliver therapeutic levels of medication from within the eye for extended periods of time.
In other words, it provides “sustained dropless therapy” to address patients who neglect to use eyedrops because of side effects associated with topical glaucoma medications.
The two iDose Phase 3 trials, which randomized 1,150 subjects across 89 clinical sites, reported positive topline outcomes, achieved primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.
The Phase 3 results are a “major milestone” for Glaukos, Burns said.
The result “powerfully reaffirms our view that iDose TR can be a transformative novel technology able to fundamentally improve the glaucoma treatment paradigm for patients,” Burns said in a statement.
“We believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained dropless pharmaceutical alternatives to traditional topical medications.”
The company is forecasting 2022 sales of $275 million to $280 million, which implies an annual decline between 4.8% to 8.2%.
The company projects its total addressable market can reach $60 billion by 2030.
Since 2018, Glaukos has spent $350 million on research and development; it has 14 disclosed pipeline programs.