Challenges to the Access and Utilization of Corneal Cross-Linking in Keratoconus Patients in the United States.

Abstract

To investigate current disparities in access to corneal cross-linking (CXL) for keratoconus patients in the United States and anticipate further disparities in the wake of Epioxa™ approval and planned Photrexa® phasing out. Perspective essay. This essay reflects on experiences from all authors in their care for keratoconus patients, a historical summary of CXL in the United States, and literature review. Corneal cross-linking (CXL) has been proven to slow progression of keratoconus and reduce the need for corneal transplants. Currently, there is only one Food and Drug Administration (FDA)-approved epithelium-off CXL protocol in the United States (KXL® system using Photrexa® or Photrexa® Viscous) and its access has been limited by high costs, insurance coverage, and proprietary protocols. The result is that underserved patients have had reduced access to treatment. In 2025, the FDA approved Epioxa™, an epithelium-on CXL therapy, under an orphan drug designation. In addition to concerns surrounding affordability, it is uncertain whether Epioxa™ has comparable short- and long-term effectiveness to Photrexa® in terms of visual acuity and maximum keratometry. With Epioxa™'s recently reported wholesale acquisition cost of $78,500, the authors feel the need to advocate for patients who will be unable to receive these potentially vision-saving therapies. Further concerning is that Photrexa® will be phased out in 2026, meaning there will no longer be an FDA-approved epithelium-off CXL therapy available in the United States. With the approval of Epioxa™ and planned phasing out of Photrexa®, we underscore the risk of exacerbating disparities in access to CXL and propose the formation of an interdisciplinary taskforce aimed at an access framework for CXL therapy for all patients. We believe the first step is to pause the phasing out of Photrexa® until (1) there is a formalized plan in place to combat the issues of CXL access as detailed here and (2) long-term efficacy of Epioxa™ can be sufficiently demonstrated.