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 wide-angle 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 end-stage 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.