Glaukos’ Epioxa for keratoconus receives permanent J-code effective summer 2026

Glaukos Corporation announced that the US Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Epioxa HD / Epioxa for the treatment of keratoconus. The new code, J2789, is scheduled to take effect July 1, 2026, according to the company.¹

Role of J-codes in reimbursement and coverage

J-codes are used by US health care providers to report physician-administered drugs and biologics and are used by government and commercial payers to facilitate billing and reimbursement. Glaukos noted the assignment of a product-specific J-code is expected to streamline the reporting and payment process for Epioxa over time.¹

“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, chairman and chief executive officer of Glaukos. “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.”¹

Background on Epioxa and keratoconus treatment

Keratoconus is a progressive corneal disorder characterized by thinning and weakening of the cornea, leading to visual impairment and, in advanced cases, corneal transplantation.² The condition is often diagnosed in younger individuals and is considered underrecognized and undertreated.²

Epioxa is a topical drug therapy used in epithelium-on corneal collagen cross-linking. According to the company, the therapy uses oxygen-enriched riboflavin formulations activated by ultraviolet light to strengthen the cornea and slow or halt disease progression.^1,2 The approach differs from traditional corneal cross-linking procedures, which typically require removal of the corneal epithelium.¹

Regulatory approval and commercial launch

The therapy received approval from the FDA in October 2025. That approval was supported by data from two prospective, randomized, multicenter, double-masked phase 3 clinical trials involving more than 400 patients, both of which met their primary effectiveness end points and demonstrated positive safety and tolerability outcomes.^2,3

Glaukos subsequently announced the commercial availability of Epioxa in March 2026, noting that the product could be ordered directly from the company or through its specialty pharmaceutical distribution network.⁴ The company also outlined plans to support patient access through co-pay assistance programs, patient assistance initiatives for uninsured individuals, and awareness campaigns aimed at improving detection and diagnosis of keratoconus.⁴

Epioxa is indicated for use in adults and pediatric patients aged 13 years and older in conjunction with the O2n System and Boost Goggles.⁴ The company has described the therapy as an incision-free alternative to conventional cross-linking procedures, with the goal of reducing discomfort associated with epithelial removal and minimizing recovery time.^1,2

The assignment of a permanent J-code represents a step in the reimbursement process that may influence how therapies are adopted in clinical practice. By enabling standardized billing, J-codes can support more consistent payer coverage and integration into healthcare systems once effective.¹

Glaukos noted that the new code has been published on the CMS website and is expected to support ongoing efforts to expand patient access to Epioxa.¹

References:

1. Glaukos receives permanent J-code for Epioxa. News release. Glaukos. April 15, 2026. Accessed April 16, 2026. https://www.businesswire.com/news/home/20260415380898/en/Glaukos-Receives-Permanent-J-code-for-Epioxa

2. Glaukos announces FDA approval of Epioxa. News release. Glaukos. October 20, 2025. Accessed October 20, 2025. https://investors.glaukos.com/news/news-details/2025/Glaukos-Announces-FDA-Approval-of-Epioxa/default.aspx

3. Stevenson S. Glaukos receives FDA approval for Epioxa topical therapy for keratoconus. Ophthalmology Times. October 20, 2025. Accessed October 20, 2025. https://www.ophthalmologytimes.com/view/glaukos-receives-fda-approval-for-epioxa-topical-therapy-for-keratoconus

4. Glaukos announces commercial availability of Epioxa, a transformative innovation in interventional keratoconus care. News release. Businesswire. March 19, 2026. Accessed March 19, 2026. https://www.businesswire.com/news/home/20260319138395/en/Glaukos-Announces-Commercial-Availability-of-Epioxa-a-Transformative-Innovation-in-Interventional-Keratoconus-Care