Ocular Photodynamic Therapy (OPT) is a new treatment for age-related macular degeneration (AMD), a common eye disease among the elderly. AMD is the leading cause of blindness in adults over the age of 50. OPT involves the infusion of an intravenous (IV) photosensitizing drug called verteporfin followed by exposure to a laser. The laser activates verteporfin, which selectively targets and treats the pathologic ocular tissue. Verteporfin was approved by the Food and Drug Administration (FDA) on April 13, 2000 and approved for inclusion in the United States Pharmacopoeia (USP) on July 18, 2000. The laser devices for use in OPT have also received FDA approval.
HCFA internally generated a national coverage review for OPT and verteporfin.
HCFA has learned of a press release issued on August 14, 2000 by QLT PhotoTherapeutics Inc. discussing plans to expand the FDA-approved indication for verteporfin for eye conditions beyond AMD. If there is scientific evidence which speaks to verteporfin’s use for indications beyond AMD which might be helpful in HCFA’s current review of OPT with verteporfin in AMD, the agency is interested in reviewing such information. If interested in submitting materials, please contact the lead analysts on this topic.