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).
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.