Glaukos Receives Permanent J-code for Epioxa™

Key Terms

j-code regulatory

A J-code is a standardized billing code used by U.S. healthcare payers to identify specific injectable or infused drugs and biologic therapies given in clinics or hospitals. For investors, J-codes matter because they determine how treatments are billed and reimbursed by insurers and government programs; having a clear code can make it easier for a medicine to be paid for and for a company to forecast sales, much like a product SKU that allows a store to track and sell an item.

hcpcs regulatory

HCPCS (Healthcare Common Procedure Coding System) is a standardized set of alphanumeric codes used by providers and insurers to describe medical services, supplies and durable equipment for billing and reimbursement. Think of it as the industry’s SKU list that determines how treatments and devices are recorded and paid for; changes to HCPCS codes or payment rules can directly affect revenue, pricing and market access for healthcare companies.

keratoconus medical

Keratoconus is an eye condition in which the cornea, the clear front surface of the eye, thins and bulges into a cone-like shape, causing distorted and often worsening vision. For investors it matters because changes in prevalence, advances in treatments, new diagnostic tools, or regulatory decisions can shift demand and revenue for medical devices, drugs and vision-care services—think of a camera lens warping and blurring the picture, creating market opportunities for firms that can fix it.

corneal epithelium medical

The corneal epithelium is the thin, clear outer layer of the eye’s front surface that protects the cornea and helps keep vision sharp, like a clear protective film over a window. For investors, it matters because many eye drugs, surgical techniques and medical devices must be safe for or aimed at healing this layer; success or failure in restoring or protecting it affects regulatory approval, clinical outcomes, patient demand and ultimately commercial value.

corneal cross-linking medical

Corneal cross-linking is a medical procedure that uses a light-activated treatment to strengthen the clear front layer of the eye, halting or slowing progressive thinning and bulging. For investors, it matters because it represents a growing demand for specialized devices, clinic services and reimbursements; successful treatments can reduce long-term costs and create recurring revenue streams similar to a one-time retrofit that preserves an expensive system from failing.

topical therapeutic medical

A topical therapeutic is a medicine formulated to be applied directly to the skin, eyes, nostrils, mouth or other body surfaces to treat a local condition rather than being swallowed or injected. For investors, this matters because these products often follow different regulatory paths, face distinct manufacturing and packaging needs, and can have faster development timelines and clearer market targeting — think of them like spot treatments designed for a specific area rather than a whole-body solution.

uv light technical

Ultraviolet (UV) light is invisible radiation from the sun and artificial lamps that sits just beyond the visible color spectrum; think of it as a higher-energy version of the light you see. Investors care because UV is used as a practical tool for disinfecting surfaces, treating water, curing inks and coatings, and in medical devices, which can create market demand, regulatory scrutiny, safety requirements and product durability issues that affect sales and costs.

New J-code for Epioxa™, J2789, set to become effective July 1, 2026

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, 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™ HD / Epioxa™ (“Epioxa”) for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated.

The 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 on the CMS website.

“The assignment of a product-specific J-code for Epioxa represents an important milestone, supporting our market access initiatives to increase access and expand coverage for patients suffering from keratoconus,” said Thomas Burns, Glaukos chairman and chief executive officer. “Once effective, this new J-code is expected to enable more streamlined and consistent coverage and payment for Epioxa over time, strengthening the foundation for our commercial launch and enabling broader patient access.”

J-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, administered by a healthcare professional.

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-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.

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, 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 “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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260415380898/en/

Media Contact:
Michele Gray
(917) 449-9250
michele@mgraycommunications.com

Investor Contact:
Chris Lewis
Vice President, Investor Relations & Corporate Affairs
clewis@glaukos.com

 

 

Source: Glaukos Corporation