Glaukos Announces Commercial Availability of Epioxa™, a Transformative Innovation in Interventional Keratoconus Care
Epioxa Provides the Ophthalmic Community and Patients with the First and Only FDA-Approved, Incision-Free, Topical Drug Therapy for Keratoconus, a Sight-Threatening Rare Disease
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 the commercial availability of Epioxa™ HD / Epioxa™ ("Epioxa"), a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare, sight-threatening corneal disease that is currently far too often undiagnosed and untreated. Epioxa is now commercially available for ordering directly from Glaukos or through its specialty pharmaceutical distribution network.
"We are delighted to announce that Epioxa is now commercially available, ushering in a new standard-of-care for patients suffering from keratoconus with the first FDA-approved topical drug therapy that does not require removal of the corneal epithelium," said Thomas Burns, Glaukos chairman and chief executive officer. "Epioxa is designed to improve patient comfort and minimize recovery time, representing a game-changing new interventional keratoconus treatment for patients. Our teams have been diligently preparing for this launch and we are excited to bring this innovative therapy to market for patients."
Epioxa represents a transformative advancement in interventional keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures. The topical therapy, catalyzed by enriched oxygen and light, is designed to reduce the pain associated with epithelium removal, streamline the procedure, and minimize recovery, all while delivering clinically meaningful outcomes and exceptional value to patients, providers, and the healthcare system.
With this launch, Glaukos plans to substantially increase its investments in patient awareness, education, and access while addressing the longstanding challenges of underdiagnosis and undertreatment that have affected this rare disease patient community. These efforts will be focused on supporting patients across every step of the journey, from awareness to diagnosis through ongoing treatment. Key initiatives include streamlined patient access support programs, including a newly formed patient access liaison team, a co-pay assistance program to reduce financial barriers, a patient assistance program for the uninsured, and new awareness and detection campaigns aimed at earlier and more widespread screening for and diagnosis of the disease. Glaukos is proud to offer these robust programs as part of its unwavering commitment to patient care, accessibility, and support.
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 are able to 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, supply or manufacturing disruptions, 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. 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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Media Contact – Corneal Health:
Michele Gray
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Investor Contact:
Chris Lewis
Vice President, Investor Relations & Corporate Affairs
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