Glaukos Receives Permanent J-code for Epioxa™

[Gretchyn Bailey]

Aliso Viejo, CA – April 15, 2026—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.

 

[Brent Swartz]

So let me see if I have this straight- Glaukos brought us "Epioxa" as a treatment for keratoconus. Glaukos is partial owned by BlackRock and others. The Glaukos group bought Avedro in 2019 who had corneal cross linking-which at the time of acquisition cost $3-$5,000/eye. So now cross linking is suddenly $78,000/eye since Glaukos group owns the rights to riboflavin. "Epioxa" cost the same. Cross linking was never covered by medical insurance- but "Epioxa" has been approved so we now have a special code for it.

I have read "Epioxa"does not perform as well as cross linking. Cross linking is still available at $3,000-$5,000/eye in the none approved FDA form. In short-insurance coverage for a sub par treatment then what we had before for an exorbitant cost.

What a mess. Please correct me if I'm am wrong

 

[Gretchyn Bailey]

@Brent Swartz would you like me to dig into this with Glaukos?

 

[Brent Swartz]

Actually, I would.

 

[Gretchyn Bailey]

I have reached out for info. I'll report back.

 

[Gretchyn Bailey]

@Brent Swartz, I contacted Glaukos for more information. I just received this statement.

Glaukos Statement
FDA approval of corneal cross-linking for keratoconus in 2016 was and remains a transformative breakthrough for patients suffering from this sight-threatening disease. Yet today, only ~10,000 patients a year undergo cross-linking, the only proven option to slow or halt disease progression, leaving potentially hundreds of thousands of patients unaware, undiagnosed, misdiagnosed, or untreated. An analysis of IRIS Registry data found that only 12% of newly diagnosed KC patients have received corneal cross-linking. Further, our data sets suggests that these treated patients are cross-linked far later than they should be – age 32 in one large data set and age 36 in another. As such, several years ago we began to challenge the way we were approaching the KC treatment paradigm and how we could do it differently to drive awareness, detection, action, and access.

With the FDA approval of Epioxa, an epithelium-on oxygen-enriched cross-linking procedure, we have an opportunity to reset the paradigm that has left far too many patients behind over the past decade.

Epioxa, a novel formulation that is held to the highest GMP standards, is proven with 2 pivotal clinical trials in almost 600 patients. There are no head-to-head trials between Photrexa and Epioxa to date so any direct comparisons would not be possible. However, it's important to consider study design and patient baseline differences when comparing efficacy data across therapies. Regarding non-FDA approved epi-on data more broadly, not all epi-on approaches are equivalent. Epioxa’s unique formulation and oxygen enrichment protocol are distinct, which creates advanced high-power photo enhancement and maximizes cross-linking efficiency.

To ensure patients can access this novel advancement in KC treatment, Glaukos has invested heavily in a comprehensive support model, EpioxaCareConnect. Eligible patients may pay as little as $0 out of pocket through our Epioxa Commercial Co-Pay Program. For eligible patients who are uninsured or otherwise unable to access Epioxa, we will provide the drug through our patient assistance program at no cost. Glaukos also offers personalized, non-clinical education through Patient Access Liaisons to navigate logistical barriers through the treatment journey. This support model is critical to ensuring broader access and protecting vision for patients with KC.

Epi-off crosslinking was previously covered by many insurances. Epioxa has already secured expanded access pathways now with more than 100 million covered commercial lives in the United States, including with 4 of the 5 largest payers reflecting encouraging initial receptivity of Epioxa's clinical value. Epioxa recently had its J code approved set to take effect on July 1, 2026, which will help streamline billing and coding for Epioxa treatment centers.