What was approved
The FDA approval covers a defined system: specific riboflavin ophthalmic solutions, with and without dextran, used with a specific ultraviolet A light source, in a protocol in which the corneal epithelium is removed before the riboflavin is applied. The indications are progressive keratoconus and corneal ectasia following refractive surgery, in patients 14 and older. The approval was based on three randomized, controlled clinical trials in the United States in which treated eyes showed a flattening of the steepest corneal curvature over a year while untreated eyes continued to steepen.
Why the approval matters to patients
- Evidence: the approved protocol is the one with controlled trial data behind it, and with long-term follow-up in Europe, where it originated
- Consistency: the drug, the light dose and the technique are standardized, so results are predictable
- Coverage: medical insurers often cover the FDA approved procedure for progressive keratoconus; unapproved variants are usually not covered
- Safety oversight: adverse events are reported and tracked as for any approved treatment
Approved versus other protocols
Several variations exist: epithelium-on techniques that leave the surface intact for a gentler recovery, accelerated protocols with higher intensity and shorter exposure, and combinations with laser reshaping. Some are used under research protocols or outside the United States, and some show promise. They do not carry FDA approval, their long term data are thinner, and insurers generally do not cover them. The approved epithelium-off protocol is the one with established effectiveness, and the cornea specialist will discuss alternatives frankly if you ask.
Eligibility under the approval
Progressive keratoconus, demonstrated by change on tomography, or ectasia after LASIK or PRK; age 14 or older; a cornea thick enough to treat safely; and no active infection or central scarring that would compromise the result. The keratoconus evaluation establishes each of these, and our team helps with insurance paperwork where needed before scheduling.
Is this right for your eyes?
Nothing on this page is a diagnosis. Whether this is the right choice for you is decided by a full examination at one of our 4 offices: Pasadena, Huntington Beach, Woodland Hills and Beverly Hills.
About this content: This page was written with the assistance of AI tools and reviewed for medical accuracy by Dr. Bavand Youssefzadeh, DO. It is general information, not medical advice, and does not replace an eye examination. Individual results vary. Read our medical disclaimer.
