VisionCare IMT goes before FDA ophthalmic panel

The FDA Ophthalmic Devices advisory panel will meet this month to make recommendations and vote on the pre-market approval filed by VisionCare Ophthalmic Technologies Inc. for its implantable miniature telescope (IMT).

Saratoga, CA-based VisionCare's IMT is a visual prosthetic device that 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, VisionCare reported 1-year efficacy data from a critical study showing that 90% of patients met the visual acuity endpoint.