Topical medications are the dominant treatment plan for about 18 million eyes affected by glaucoma and ocular hypertension, yet research shows 90% of patients are non-compliant with topical medication use and 50% purposely discontinue their medication within six months.
The reasons include costs, forgetfulness, complex dosing regimens and the difficulty of administering eye drops plus some side effects like toxicity, according to Aliso Viejo-based Glaukos Corp. (NYSE: GKOS).
“The current ‘meds-first, give ground’ disease progression algorithm must be challenged,” declared a Glaukos presentation shown at JP Morgan’s annual healthcare conference on Jan. 10.
Glaukos’ proposed new algorithm is implanting a tiny device into the eye called iDose TR that for as long as three years releases into the anterior chamber a proprietary formulation of travoprost, a medicine used to lower intraocular pressure.
Instead of a typical 2,190 eye drops administered per eye during a three-year period, a patient only needs “one administration” of iDose.
Glaukos plans to submit a new drug application this quarter to the Food and Drug Administration, which may approve it this year.
IDose has an estimated U.S. opportunity of 3 million eyes. Earlier this month, Glaukos revealed a trial where a surgeon took original iDose TR implants and replaced them with new ones. The exchange trial suggests removal and replacement was “safe and well-tolerated.”
“IDose should become a game-changing device within ophthalmology,” Chief Executive Thomas Burns told the JP Morgan conference.
Glaukos, founded in 1998, is best known for the iStent, which is among the smallest medical devices ever made and has been implanted in more than 1 million eyes worldwide to treat glaucoma.
The company has struggled in the past couple years due to both the coronavirus limiting surgeries and Medicaid reducing payments for its products. Analysts are predicting 2022 revenue will fall 4.9% to $294 million and sales will return to growth in 2023 by increasing 9% to $304.7 million.
Burns highlighted the company’s research, saying it’s invested $400 million in research and development since 2018. While it had four disclosed pipeline programs in 2015, it now has 14 such projects.
Glaukos on Jan. 10 also announced milestones on two other ongoing trials.
It’s commenced subject enrollment for its Phase 3 confirmatory trial for Epioxa, its next-generation corneal cross-linking therapy for the treatment of keratoconus, an eye disease that typically affects younger people.
The company also announced promising topline results from its Phase 2a first-in-human clinical trial for a cream that is rubbed on eyelids to treat dry eye disease with the idea of replacing eye drops that might be difficult for elderly patients to use.
Investors have been impressed with those announcements and Burns’ hint of a better-than-expected fourth quarter.
The shares have risen 8.4% since Jan. 10 to $48.42 and a $2.3 billion market cap. The company plans to announce fourth-quarter results in the coming weeks.