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

OBJECTIVE OR PURPOSE: To investigate current disparities in access to corneal cross-linking (CXL) for patients with keratoconus in the United States and to anticipate further disparities in the wake of Epioxa approval and planned Photrexa phasing out.

DESIGN

Perspective essay.

METHODS, INTERVENTION, OR TESTING: This essay reflects on experiences from all authors in their care for patients with keratoconus, a historical summary of CXL in the United States, and a literature review.

RESULTS

CXL has been proven to slow the progression of keratoconus and reduce the need for corneal transplants. Currently, there is only 1 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.

CONCLUSIONS

With the approval of Epioxa and the planned phasing out of Photrexa, we underscore the risk of exacerbating disparities in access to CXL and propose the formation of an interdisciplinary task force aimed at developing an access framework for CXL therapy for all patients. We believe that 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) the long-term efficacy of Epioxa can be sufficiently demonstrated.