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FDA Advisory Panel Recommends Approval of VisionCare's Implantable Telescope for End-Stage Macular Degeneration
Date:3/30/2009

SARATOGA, Calif., March 30 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), today announced the FDA Ophthalmic Devices Advisory Panel unanimously recommended that the FDA approve, with conditions, the premarket application (PMA) for its implantable telescope for End-Stage AMD. The implantable telescope is the first medical device to be recommended by the panel for FDA approval for End-Stage AMD, a leading cause of untreatable blindness in the U.S.

The FDA usually follows the recommendations of an advisory panel, but is not required to do so. The panel recommended approval of the device with conditions including post-approval surveillance and labeling suggestions. The panel decision was reached by a vote of 8 to 0.

"We are pleased with the panel's recommendation for approval and will work closely with FDA to address the approval conditions," said Allen W. Hill, CEO of VisionCare. "We look forward to providing the ophthalmic community a new treatment option to improve vision and quality of life for patients with untreatable, end-stage age-related macular degeneration."

Data from clinical studies were presented to the panel by the following leading surgeons and vision experts at the March 27, 2009 Ophthalmic Advisory Panel Meeting:

  • R. Doyle Stulting, MD, PhD, Professor of Ophthalmology, Director of Cornea Service, Emory University.
  • Stephen Lane, MD, Clinical Professor of Ophthalmology, University of Minnesota and in private practice at Associated Eye Care, Stillwater, MN.
  • Oliver Schein, MD, MPH, Burton E. Grossman Professor of Ophthalmology, Director of Comprehensive Eye Services at The Wilmer Eye Institute, Johns Hopkins University.
  • Eli Peli, MSc, OD, Senior Scientist and the Moakley
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SOURCE VisionCare Ophthalmic Technologies, Inc.
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