MEDICAL DEVICE INNOVATION - Medical Device Daily

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FDA panel gives thumbs up to
telescope for end-stage AMD
MEDICAL DEVICE INNOVATION 2010
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
A device that sounds a bit like something Inspector
Gadget might use may soon be an available treatment
option for people with end-stage age-related macular
degeneration (AMD).
An FDA advisory panel has recommended that the
agency approve, with conditions, the premarket application
for a tiny implantable telescope for end-stage AMD.
The implantable telescope is the first device to be recommended
by the FDA Ophthalmic Devices Advisory Panel for
the disease.
If the FDA follows the panel’s recommendation,
VisionCare (Saratoga, California) may be able to market
its device in the U.S. as early as the third quarter, or four to
five months from now, President/CEO Allen Hill told
Medical Device Daily. Although the agency usually follows
the recommendations of an advisory panel, it is not
required to do so.
“We are pleased with the panel’s recommendation for
approval and will work closely with FDA to address the
approval conditions,” Hill said. “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.”
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. Hill said the implantable telescope is
intended for patients with a visual acuity no better than
20/80 and no worse than 20/800.
Smaller than a pea, the telescope prosthetic device
works like a fixed-focus telephoto lens in a camera, Hill
said. A mono-vision device, it is implanted in one eye during
an outpatient surgical procedure. He said it goes in the
same place an intraocular lens would go. 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.
The device is only 4 mm long and contains two wideangle
microlenses, VisionCare noted. According to the
company, the telescope, together with the cornea, can
enlarge images up to three times, depending on the model
used. The telephoto effect allows images in the central
visual field to not be focused directly on the damaged macula,
but over other healthy areas of the central and peripheral
retina. This generally helps reduce the blind spot
impairing vision in patients with AMD, hopefully improving
their ability to recognize images that were either difficult
or impossible to see, VisionCare said.
After the procedure, the patient participates in a structured
vision rehabilitation program to maximize their ability
to perform daily activities, the company noted.
VisionCare said the device allows patients to use natural
eye movements to scan the environment and reading materials.
According to the company, the telescope is virtually
unnoticeable to others because it is completely implanted
inside the eye and mostly covered by the iris, the colored
portion of the eye.
Hill told MDD there are no similar devices on the market
or under investigation in the U.S. for end-stage AMD. He
said VisionCare estimates that there are 50,000 to 60,000
new cases of the disease each year. According to the
National Eye Institute (Bethesda, Maryland) over 1.7 million
Americans over age 50 suffer mild to profound vision loss
from advanced AMD, which frequently culminates as endstage
AMD (visual impairment due to untreatable advanced
AMD).
VisionCare is a privately-held company. The
Implantable Miniature Telescope was invented by company
founders, Yossi Gross and Isaac Lipshitz.
(This story originally appeared in the April 1, 2009, edition
of Medical Device Daily).
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