Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: riboflavin 5'-phosphate
Trade Name: Epioxa HD and Epioxa
Date Designated: 09/02/2011
Orphan Designation: Treatment of keratoconus
Orphan Designation Status: Designated/Approved
Glaukos Corporation
One Glaukos Way
Aliso Viejo, California 92656
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: riboflavin 5'-phosphate
Trade Name: Epioxa HD and Epioxa
Marketing Approval Date: 10/17/2025
Approved Labeled Indication: in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n System and the Boost Goggles
Exclusivity End Date: TBD  
Generic Name: riboflavin ophthalmic solution & ultraviolet A
Trade Name: Photrexa Viscous
Date Designated: 09/02/2011
Orphan Designation: Treatment of keratoconus
Orphan Designation Status: Designated/Approved
Glaukos Corporation
One Glaukos Way
Aliso Viejo, California 92656
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: riboflavin ophthalmic solution & ultraviolet A
Trade Name: Photrexa Viscous
Marketing Approval Date: 04/15/2016
Approved Labeled Indication: Indicated for use in corneal collagen crosslinking in combination with the KXL¿ System for the treatment of progressive keratoconus
Exclusivity End Date: 04/15/2023 
Exclusivity Protected Indication* :  Treatment of progressive keratoconus
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-