October 6, 2010
"Implanted telescope restores sight to blind."
28 Sep 2010
Remarkable optical system that treats central vision blindness caused by end-stage macular degeneration recently received FDA approval.
The challenges involved in developing an implantable optical device to give sight back to sufferers of end-stage age-related macular degeneration (AMD) are nothing short of immense. Not only must developers understand the disease and create a device that will bring maximum benefit to the patient, there are biocompatibility and sterility issues to address - plus of course the key issue of how to implant the device into the eye itself.
But following a clinical trial involving more than 200 patients at 28 leading ophthalmology clinics across the US and now with the all important FDA approval under its belt, VisionCare Ophthalmic Technologies, a privately held specialty medical device company based in California, is finally in a position to offer end-stage AMD patients its implantable telescope technology.
“Our device is the first of its kind. It is the first FDA-approved implantable medical device demonstrated to improve visual acuity and quality of life in individuals with end-stage AMD,” Chet Kumar, VisionCare’s VP of business and market development, told optics.org. “There is truly an un-met need for these patients as no drugs or surgical procedures are available to reverse the effects of macular degeneration.”
What is end-stage AMD?
A healthy eye uses several elements, such as the lens at its front, and the light-sensitive retina at its rear, to provide clear vision. Packed with a high density of light-sensitive cells, the macula is a small area of the retina that produces the highest-resolution images used for central vision. AMD is a disease of the macula that leads to varying levels of central vision loss.
In the case of end-stage AMD, a patient will suffer from complete central vision blindness, which is permanent as currently there is no way to repair the macula. Estimates suggest that as many as 750,000 people in the US are currently suffering from end-stage AMD, living with a central blind spot in both eyes.
Fortunately, the cells that are responsible for peripheral vision – albeit at a lower resolution than central vision – are not attacked by AMD. And this is what VisionCare exploits with its implantable telescope technology. “In the simplest terms, our device helps patients to see by projecting the central image around the degenerated macula instead of on to it, thus utilizing healthier, preferred retinal photoreceptors,” explained Eli Aharoni, the VP of research and development and general manager of VisionCare Ltd.
VisionCare was founded in Israel in 1997 to commercialize the implantable telescope technology that was the brainchild of an ophthalmologist called Isaac Lipshitz and prolific inventor Yossi Gross. In 2000, the company restructured and moved its headquarters to the US, where it is now led by president and CEO Allen Hill. Its research and manufacturing activities remain in Israel and are headed up by Eli Aharoni. To date, the company has raised a total of $59 million in venture capital funding.
As Aharoni explains, simply knowing where to start was a major difficulty. “The initial challenges were in understanding the disease and then how to build a device that can meet the patient’s needs,” he said. “We had to consider many optical parameters, the mechanical engineering to produce the device to tight tolerances, the biocompatibility of our materials and their sterility and stability inside the eye. The final task was to develop a surgical procedure to implant it in the eye, which was a challenge requiring coordination between both engineers and surgeons.”
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