Glaukos Announces Completion of Patient Enrollment in Phase 2 Study of GLK-321 for Demodex Blepharitis

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, today announced completion of patient enrollment in its Phase 2 clinical study evaluating GLK-321 for the treatment of Demodex blepharitis.

GLK-321 is an investigational drug candidate using Glaukos’ proprietary iLution platform, a novel ophthalmic drug-delivery system utilizing patented, cream-based drug formulations applied to the outer surface of the eyelids to enable dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. The platform is designed to improve patient compliance, offer faster onset of action, and reduce side effects and patient burden often associated with traditional eye drop regimens. GLK-321’s active pharmaceutical ingredient is physostigmine.

“Completion of enrollment in this Phase 2 study marks an important milestone in the advancement of our iLution pharmaceutical platform and broader ocular surface disease pipeline,” said Thomas Burns, Glaukos chairman and chief executive officer. “Demodex blepharitis represents a large, growing, and significantly underpenetrated market opportunity, with potentially millions of patients who remain undiagnosed or untreated today. As awareness and diagnosis of this chronic condition continue to increase, we believe there is a substantial need for differentiated therapeutic approaches that expand treatment options and improve patient access to care.”

Demodex blepharitis is a chronic eyelid disease associated with Demodex mite infestation and is characterized by eyelid inflammation, irritation, redness, itching, and the presence of collarettes at the base of eyelashes. The disease is believed to be significantly underdiagnosed and can adversely affect ocular surface health and patient quality of life.

The Phase 2 randomized, double-masked, placebo-controlled, dose-ranging, parallel-group, multi-center trial is designed to evaluate the safety, tolerability, and efficacy of three different dose levels of GLK-321 in patients with Demodex blepharitis. The study randomized 275 patients across clinical sites in the United States, with the primary efficacy endpoint assessing the proportion of study eyes achieving elimination of collarettes following six weeks of treatment.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, Glaukos commenced commercial launch activities for iDose^® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rare corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.

Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which we obtain regulatory approval for investigational products such as GLK-321, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety profile of our products. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 23, 2026, along with Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which was filed with the SEC on April 30, 2026. Our filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.