FDA Sponsor-Investigator Warning letter: NVISION Laser Eye Centers

FDA issued a warning letter this week to a Clinical Investigator, who was acting as both the sponsor and the investigator for a “Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 in Eyes with Keratoconus or Ectasia”. 

Dr. Toomey was warned for:

  • Failing to submit an IND for the study
    • FDA notes that the PI stated that neither the IRB, nor the distributor of the riboflavin ophthalmic solution, and nor other ophthalmologists inform him that an IND was required
    • FDA notes that corneal crosslinking with riboflavin for the treatment of keratoconus and ectasia is not approved in the United States.
  • Failing to ensure proper monitoring
    • FDA notes that the Sponsor-Investigator depended on the other surgeons to collect accurate data and there was no monitoring of the study
  • Failure to maintain adequate accountability records
    • No accountability records were maintained at the seven sites where subjects were enrolled