Implantable Miniature Telescope for AMD From VisionCare Ophthalmic Technologies Secures Approval From FDA Ophthalmic Devices Advisory Panel
April 2, 2009
Earlier this week, VisionCare Ophthalmic Technologies, Inc., (“VOT”) a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), announced that the FDA Ophthalmic Devices Advisory Panel unanimously recommended that the FDA approve, with conditions, the premarket application (PMA) for VOT’s Implantable Miniature Telescope (“IMT”) for End-Stage AMD. The IMT is the first medical device to be recommended by the panel for FDA approval for End-Stage AMD.
The FDA usually follows the recommendations of an advisory panel, but is not required to do so.
Data from clinical studies conducted by leading eye surgeons and vision experts was presented to the panel. 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 8to 0.
Approval came despite the device’s association with loss of corneal cells over time. According to an article on medpage Today, four years after the implant, about 15% of patients will have a significant depletion in endothelial cells, which can lead to corneal edema, according to an estimate by the panel’s biostatistician, Karen Bandeen-Roche, Ph.D., of Johns Hopkins University in Baltimore.
An earlier application by VisionCare for the device in 2006 had been rejected due to the higher-than-expected cell loss in the implanted eye. As reported in the medpage Today article referenced above, the current application had a much narrower indication than the earlier one. The device was originally intended for patients 55 and older, but the sponsors bumped the age requirement up to 65. The new application also excludes patients with corneal guttata, and those who have an anterior chamber depth of less than 3 mm. Patients must also have retinal cell counts that are normal for their age group before receiving the implant.
The IMT 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.
As described by the company, the implanted telescope, together with the cornea, acts as a telephoto system to enlarge images 3X or 2.2X, depending on the device model used. The telephoto effect allows images in the central visual field (‘straight ahead vision’) 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.
The prosthetic telescope is implanted by an ophthalmic surgeon in an outpatient surgical procedure. The device is implanted in one eye, which provides central vision as described above, while the non-implanted eye provides peripheral vision for mobility and navigation. After the surgical procedure, the patient participates in a structured vision rehabilitation program to maximize their ability to perform daily activities. Situated in the eye, the device allows patients to use natural eye movements to scan the environment and reading materials.
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