Glaukos Announces Positive Three-Year Epioxa® Results Demonstrating Durable Clinical Outcomes in Keratoconus
Three-year data demonstrate sustained improvements in corneal shape, meaningful visual acuity gains, and a favorable
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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, announced today positive topline results from a long-term Phase 3 extension study (GLK-202-03) evaluating the durability, visual outcomes, and safety of Epioxa®, the company’s groundbreaking epi-on corneal cross-linking therapy for the treatment of keratoconus, a sight-threatening corneal disease that remains significantly undiagnosed and undertreated. The extension study followed a cohort of patients for three years after cross-linking treatment in Epioxa’s second Phase 3 pivotal trial (GLK-202-02).
The long-term follow-up results demonstrated durable efficacy and a favorable long-term safety profile through three years following a single Epioxa treatment, with no additional intervention during the extension period. Treated eyes achieved a sustained 1.9 diopter (D) improvement in maximum corneal curvature (Kmax) from baseline, reflecting meaningful long-term corneal flattening and stabilization. Treated eyes also demonstrated clinically meaningful visual outcomes at year 3, with 29% and 20% of eyes gaining two or more and three or more lines of best-corrected visual acuity from baseline, respectively. The durability of these findings further supports Epioxa’s potential to provide long-term disease stabilization following a single treatment. In addition, treated eyes maintained a favorable long-term safety profile through three years, with no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events.
“These long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with keratoconus,” said Thomas Burns, chairman and chief executive officer of Glaukos. “The sustained improvements in corneal shape and visual acuity, coupled with an excellent long-term safety profile, reinforce our view that Epioxa represents a transformative treatment advancement for keratoconus patients.”
GLK-202-03 is a long-term extension study designed to evaluate the safety, durability, and clinical outcomes of a cohort of patients who completed the Phase 3 GLK-202-02 trial and received corneal cross-linking treatment during the initial study period. Patients were followed for up to 3 years after treatment, with efficacy assessments focused on changes in corneal curvature and visual acuity. A total of 38 study eyes from 35 subjects participated, and 92% of eyes completed the year 3 visit.
Epioxa represents a transformative innovation in keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures as it does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. This novel, oxygen-supplemented topical therapeutic, bioactivated by pulsed UV light, is designed to significantly reduce the pain associated with removal of the epithelium, streamline the procedure, and minimize recovery, all while delivering robust clinically meaningful and durable outcomes and exceptional value to patients, providers, and the healthcare system.
For more information about Epioxa HD / Epioxa and Full Prescribing Information, please visit www.Epioxa.com.
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.
About Epioxa HD / Epioxa
Indication: EPIOXA HD (riboflavin 5’-phosphate ophthalmic solution) 0.239% and EPIOXA (riboflavin 5’-phosphate ophthalmic solution) 0.177% are photoenhancers indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n® System and the Boost Goggles®.
Dosage and Administration: EPIOXA HD and EPIOXA are for topical ophthalmic use. NOT for injection or intraocular use. EPIOXA HD and EPIOXA are supplied in single-dose syringes. Discard opened syringes after use. EPIOXA HD and EPIOXA are for use with the O2n System and Boost Goggles only. Refer to the O2n System Operator’s Manual and Boost Goggles User Guide for device instructions.
Contraindications: EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA. Epithelium-on corneal collagen cross-linking is contraindicated in aphakic and pseudophakic patients without a UV-blocking intraocular lens.
Warnings and Precautions: Corneal collagen cross-linking should be used with caution in patients with a history of herpetic keratitis due to the potential for reactivation of herpes keratitis.
Adverse Reactions: The most common adverse reaction was conjunctival hyperaemia (31%). Other adverse reactions, occurring in 5% to 25% of eyes included: corneal opacity (haze), photophobia, punctate keratitis, eye pain, eye irritation, increased lacrimation, corneal epithelium defect, eyelid oedema, corneal striae, visual acuity reduced, dry eye, and anterior chamber flare.
For more information, visit www.glaukos.com.
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, 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, which was filed with the SEC on July 29, 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.
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