\nGlaukos 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 U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Epioxa\u2122 HD \/ Epioxa\u2122 (\u201cEpioxa\u201d) for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated.<\/p>\n
\nThe new J-code for Epioxa, J2789, is set to become effective July 1, 2026. It is expected to streamline the reporting and payment of Epioxa by U.S. payers over time, and has been published here<\/a> on the CMS website.<\/p>\n \n\u201cThe assignment of a product-specific J-code for Epioxa <\/i>representsan important milestone, supporting our market access initiatives to increase access and expand coverage for patients suffering from keratoconus,\u201d said Thomas Burns, Glaukos chairman and chief executive officer. \u201cOnce effective, this new J-code is expected to enable more streamlined and consistent coverage and payment for Epioxaover time, strengthening the foundation for our commercial launch and enabling broader patient access.\u201d<\/p>\n \nJ-codes are reported by U.S. healthcare providers and used by U.S. government and commercial payers to streamline the billing and reimbursement process for pharmaceuticals, such as Epioxa<\/i>, administered by a healthcare professional.<\/p>\n \nEpioxa 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-enriched topical therapeutic, bioactivated by UV light, is designed to eliminate the pain associated with removal of the epithelium, streamline the procedure, and minimize recovery, all while delivering clinically meaningful outcomes and exceptional value to patients, providers, and the healthcare system.<\/p>\n About Glaukos<\/b><\/p>\n \nGlaukos (www.glaukos.com<\/a>) 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\u00ae<\/sup> TR<\/i>, 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.<\/p>\n About<\/i><\/b>Epioxa HD \/ Epioxa<\/b><\/i><\/p>\n \nIndication: EPIOXA\u2122 HD (riboflavin 5\u2019-phosphate ophthalmic solution) 0.239% and EPIOXA\u2122 (riboflavin 5\u2019-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 O2<\/sub>n\u2122 System and the Boost Goggles\u00ae<\/sup>.<\/p>\n \nDosage 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 O2<\/sub>n System and Boost Goggles only. Refer to the O2<\/sub>n System Operator\u2019s Manual and Boost Goggles User Guide for device instructions.<\/p>\n \nContraindications: 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.<\/p>\n \nWarnings 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.<\/p>\n \nAdverse 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.<\/p>\n \nFor more information, visit www.glaukos.com<\/a>.<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nAll 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, the continued efficacy and safety profile of our products, and the extent to which this new J-code will enable more streamlined and consistent coverage and payment for Epioxa over time. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption \u201cRisk Factors\u201d 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<\/a> or at www.sec.gov<\/a>. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com<\/a>. 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.<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260415380898\/en\/<\/a><\/span><\/p>\n \nMedia Contact: \nInvestor Contact: \n\u00a0<\/p>\n \n\u00a0<\/p>\n KEYWORDS:<\/b> California United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Surgery Infectious Diseases FDA Clinical Trials Health Technology Health Pharmaceutical General Health Optical<\/p>\n<\/p>\n
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Michele Gray
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(917) 449-9250
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michele@mgraycommunications.com<\/a><\/p>\n
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Chris Lewis
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Vice President, Investor Relations & Corporate Affairs
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clewis@glaukos.com<\/a><\/p>\n
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