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The premarket application for VisionCare Ophthalmic Technologies Inc's implantable telescope for end-stage AMD has been approved, with conditions, by the FDA in the US.
The premarket application for VisionCare Ophthalmic Technologies Inc's implantable telescope for end-stage age-related macular degeneration (AMD) has been approved, with conditions, by the FDA in the US.
The conditions included post-approval surveillance and labelling suggestions. CEO of VisionCare, Allen W. Hill said: "We look forward to providing the ophthalmic community with a new treatment option to improve vision and quality of life for patients with untreatable, end-stage age-related macular degeneration."
The investigative Implantable Miniature Telescope designed 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.