FDA Advisory Panel Recommends Approval of VisionCare's Implantable Telescope for End-Stage Macular Degeneration
March 30 2009 - 5:42PM
PR Newswire (US)
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 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/. DATASOURCE: VisionCare Ophthalmic
Technologies, Inc. CONTACT: Allen Hill, President and CEO of
VisionCare Ophthalmic Technologies, Inc., +1-408-872-9393, Web
Site: http://www.visioncareinc.net/
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