This article is more than 5 years old. Information may no longer be current.
Laser companies receive approvable letters for AMD treatment
WASHINGTON — The Food and Drug Administration (FDA) on Feb. 11 issued an approvable letter for two lasers to treat the wet form of age-related macular degeneration (AMD).
The letter indicates the FDA will, after final review, approve the Opal Photoactivator (Coherent Inc., Santa Clara, Calif.), Zeiss Visulas 690s laser (Zeiss Humphrey Systems, Dublin, Calif.) for use with Visudyne verteporfin for injection (CIBA Vision; Duluth, Ga.) as appropriate for patients with the wet form of AMD.
CIBA Vision and QLT PhotoTherapeutics (Vancouver, British Columbia) recently received an approval letter for Visudyne therapy. (See related stories, pages 19 and 64.)
Visudyne therapy is a two-step procedure that can be performed in a doctor’s office. First, verteprofin is injected intravenously into the patient’s arm. The drug is then activated by the administration of a laser pulse through the patient’s pupil in a noninvasive procedure lasting 83 seconds.
Jim Taylor, president of Coherent Medical Group, stated, “Coherent is proud to have developed the laser technology that activates the Visudyne therapeutic drug and to be a partner in the battle to prevent blindness from AMD. Early adoption of the therapy is expected to be high.”
David Smith, vice president of worldwide marketing for Zeiss Humphrey Systems said, “We are extremely encouraged by the results of the clinical trials and the approvable status of the therapy. This represents a significant step toward improving the lives of thousands of people around the world.”