FDA panel recommends for approval VisionCare's implantable telescope for AMD
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SARATOGA, Calif. The U.S. Food and Drug Administration's Ophthalmic Devices Advisory Panel has unanimously recommended that the FDA approve, with conditions, VisionCare Ophthalmic Technologies' premarket application for its implantable telescope therapy for end-stage age-related macular degeneration, the company announced in a press release.
The panel's specified conditions include mandatory post-approval surveillance and labeling suggestions, the release said.
The implantable telescope is the first medical device recommended by the panel for FDA approval for end-stage AMD. The FDA is not bound to follow the recommendations of its advisory panels, but in most cases it does.