FDA Advisory Panel Recommends Approval of VisionCare's Implantable Telescope for...

FDA Advisory Panel Recommends Approval of VisionCare's Implantable Telescope
for End-Stage Macular Degeneration

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 www.visioncareinc.net.

SOURCE VisionCare Ophthalmic Technologies, Inc.

Allen Hill, President and CEO of VisionCare Ophthalmic Technologies, Inc.,
+1-408-872-9393, mail@visioncareinc.net