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

American Journal of Ophthalmology·July 29
OphthalmologyPractice changingSafety signalKeratoconusPerspective EssayCorneal Cross-LinkingMixedEpioxaPhotrexaPhotrexa Viscous

Summary

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What was studied

This perspective essay examines disparities in access to corneal cross-linking (CXL) for keratoconus patients in the United States, focusing on the transition from the FDA-approved epithelium-off protocol (Photrexa/KXL) to the newly approved (2025) epithelium-on therapy Epioxa, and the implications of Photrexa's planned 2026 phase-out.

Key findings

Epioxa's wholesale acquisition cost is $78,500; its short- and long-term efficacy (visual acuity, maximum keratometry) compared to Photrexa remains unproven. Photrexa's phase-out in 2026 will leave no FDA-approved epithelium-off CXL option in the US, risking worsened access disparities for underserved patients.

Study limitations

This is an expert perspective essay, not an original research study—conclusions are based on clinical experience and a literature review rather than new primary data. Long-term comparative efficacy data for Epioxa vs. Photrexa are not yet available.

Clinical implications

Clinicians should be aware that as of 2026, Photrexa is being phased out and Epioxa (at $78,500 WAC) is the only FDA-approved CXL option in the US, with unconfirmed equivalence to epithelium-off CXL. Advocating for insurance coverage and access programs is critical, especially for underserved patients at risk of corneal transplant without treatment.

Caveats

  • No sample size is applicable; findings are based on clinical experience and literature review, not a study cohort.
  • Photrexa phase-out date cited as 2026; given today's date (September 8, 2026), the current availability status of Photrexa should be independently verified.
  • This is a perspective/opinion essay, not an empirical study — level of evidence is expert opinion only.
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  • Two impact flags applied (safety_signal for unproven Epioxa efficacy post-Photrexa phase-out; practice_changing for the regulatory and access landscape shift) — clinicians should weigh these in context of the essay's advocacy nature.

Related Questions

Explore related topics

What is the evidence for epithelium-on vs epithelium-off corneal cross-linking efficacy in keratoconus?How do insurance coverage and cost barriers affect corneal cross-linking access for underserved patients?What are the clinical outcomes of Epioxa compared to Photrexa for keratoconus progression?

Publication Details

Year
2026
Journal
American Journal of Ophthalmology
Source
View article
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