Macular degeneration, a common cause of blindness in the elderly, may become a much more treatable problem in its end stages, thanks to a new implantable device which the Food and Drug Administration said Tuesday it has approved.
The approval means the device, essentially a tiny telescope made by VisionCare Opthalmic Technologies Inc., a private company based in Saratoga, Calif. was demonstrated to be safe and effective.
The FDA said it was the first time the agency had approved such a device for treating the serious problem.
The macula is the part of the retina responsible for the fine detail we see. When it is damaged by the condition, individuals can lose a good deal of their ability to recognize faces and other everyday sights most of us take for granted.
An excerpt from VisionCare's news release:
The Implantable Miniature Telescope (by Dr. Isaac Lipshitz) is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe to profound vision impairment (best-corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas (blind areas) associated with end-stage AMD. This level of visual impairment constitutes statutory (legal) blindness.
Smaller than a pea, the telescope 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 company has a good explainer of the telescope technology complete with a video on its web site.
Allen Hill, chief executive officer of VisionCare, told Reuters that 70,000 to 80,000 people in the U.S. have advanced age-related macular degeneration, giving a sense of the potential market.
But the new treatment which can be performed on an outpatient basis isn't cheap. An snippet from Reuters:
Hill said the procedure, which will be done on an outpatient basis, will cost $17,000 to $20,000, with the implant comprising a significant proportion of that.
The price raises the possibility that the new device could be yet another example of a medical miracle that winds up adding to the upward cost pressures of health care.
But blindness in the elderly obviously has a cost, too, that could be even higher economically than the price of implanting the new device.
Certainly, the emotional costs of blindness from macular degeneration are very high.