FDA ADVISORY PANEL GIVES THUMBS DOWN TO OPHTHALMIC MINI-TELESCOPE

An FDA advisory panel July 14 recommended 10-3 against approving a tiny implantable ophthalmic telescope for older patients.

The implantable miniature telescope, manufactured by VisionCare Ophthalmic Technologies of Saratoga, Calif., was rejected for safety reasons, according to the FDA. The agency generally follows the advice of these panels, meaning it is unlikely to be approved until the manufacturer addresses the panel's concerns.

The device is designed to be implanted in the eyes of elderly patients to counter the effects of age-related macular degeneration and improve central vision, but it does not cure blindness, according to VisionCare.

A safety summary will be posted on the FDA website shortly, an agency spokeswoman said.