A U.S. company has taken a giant step in the bionic eye market by implanting tiny telescopes into the eyes of patients suffering from macular degeneration. VisionCare Ophthalmic Technologies, a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), has announced the Food and Drug Authority (FDA) Ophthalmic Devices Advisory Panel has unanimously recommended that the FDA approve, with conditions, the pre-market application 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. and Australia. It has already undergone successful human trials.
“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.
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In the implanted eye, the device renders enlarged central vision images over a wide are of the retina to improve vision, while the non-operated eye provides peripheral vision for mobility and orientation.
“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.”
Mr. Hill said the investigational Implantable Miniature Telescope (IMT) was 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.
The efficacy of implantable mini telescope was first published in the American Journal of Ophthalmology in November last year following two years of trials which showed substantial visual acuity improvement in End-Stage AMD patients. The study device, a first-ofkind implantable telescope, has received CE Mark approval in Europe and is currently investigational and under regulatory review by the U.S. Food and Drug Administration.
According to the company, the publication detailed the two-year safety profile of the device and found rates of cornea endothelial cell loss, while higher than conventional smallincision anterior segment eye surgery, were consistent with anterior segment procedures employing more similar incision sizes required for telescope implantation.
“The published data show improved visual acuity in end-stage AMD patients that was maintained over two years – a three-line improvement that we have previously shown makes a real impact on our patients’ independence and quality of life,” said Dr. Henry Hudson, lead author for the IMT002 study and retina specialist at Retina Centres in Arizona.
“These findings are important because vision loss from end-stage AMD profoundly affects both the daily activities and social well-being of many older Americans,” he said.
“The data presented in AJO confirm the effectiveness of the AMD telescope prosthesis and the long-term safety profile of the device,” stated R. Doyle Stulting, Professor of Ophthalmology at Emory University in Atlanta and study co-author.
“Key indicators of corneal health and diagnostic verification of device placement substantiate earlier findings that risks of surgery are outweighed by the benefits the improved vision brings to these patients’ lives.”
According to Dr. Stephen Lane, the trial’s medical monitor: “We hope these published results will lead to a new treatment option for patients with end-stage AMD. Across the 28 centres in the study, we were able to provide a novel approach for patients whom we have not had any solutions to improve visual acuity in a functional way.”
The FDA gave the “tele-eyes” their unanimous approval in March, and the full board is expected to give its blessing later this year. Europe is already using it.
