FDA ophthalmic panel to convene
This article was originally published in The Gray Sheet
Executive Summary
The agency's ophthalmic devices advisory panel will meet July 14 to make recommendations and vote on VisionCare's PMA for an implantable miniature telescope. The firm's IMT is a visual prosthetic device, which works in combination with the optics of the cornea to create a telephoto lens. The device is used to treat bilateral, stable, macular degeneration and other bilateral, stable untreatable central vision disorders. In 2005, the Saratoga, Calif. startup reported one-year efficacy data from a pivotal study showing that 90% of patients met the visual acuity endpoint...
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