FDA Advisory Panel Recommends Approval Of VisionCare's Implantable Telescope For End Stage Macular Degeneration

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 31 Mar 2009 - 1:00 PDT

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VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), 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 Scholar in Aging Eye Research at The Schepens Eye Research Institute, and Professor of Ophthalmology at Harvard Medical School.

End-Stage AMD occurs when the macula in each eye is irreversibly degenerated and no longer provides detailed central vision required for common everyday activities such as recognizing people and facial expressions, or watching television. End-Stage AMD is characterized by central scotomas, or blind spots, in both eyes that cause images in the central visual field to be unrecognizable or not visible at all.

About the Telescope Device

The investigational Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) is designed to be a solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options. Smaller than a pea, the telescope prosthetic device is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.

About Macular Degeneration

Macular degeneration is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like recognizing faces and watching television. According to the National Eye Institute over 1.7 million Americans over age 50 suffer mild to profound vision loss from advanced AMD, which frequently culminates as End-Stage AMD (visual impairment due to untreatable advanced AMD). Patients affected in both eyes often experience a loss of independence, social interaction, and have difficulty with activities of daily living requiring detailed vision. Approximately half of the individuals living with advanced AMD are affected in both eyes.

About VisionCare

VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA is a privately-held company focused on development, manufacturing, and marketing of visual prosthetic devices. The Implantable Miniature Telescope was invented by company founders, Yossi Gross and Isaac Lipshitz. Information on VisionCare can be found at http://www.visioncareinc.net.

VisionCare Ophthalmic Technologies, Inc.
http://www.visioncareinc.net

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