VisionCare granted postponement of FDA review of implantable telescope for AMD

May 11, 2008

Rockville, MD-The FDA has postponed a review of an investigational prosthetic device for the treatment of age-related macular degeneration (AMD) at the request of its developer, VisionCare Ophthalmic Technologies Inc., so that the company can submit additional long-term clinical data.

Rockville, MD-The FDA has postponed a review of an investigational prosthetic device for the treatment of age-related macular degeneration (AMD) at the request of its developer, VisionCare Ophthalmic Technologies Inc., so that the company can submit additional long-term clinical data. The hearing for the device (Implantable Miniature Telescope) had been scheduled for April 24.

“VisionCare will be submitting additional data to [the] FDA that we believe will be helpful in completing the review and regulatory approval determination regarding the company's pre-market approval [PMA] application for our implantable telescope,” said Allen W. Hill, chief executive officer of VisionCare, based in Saratoga, CA. “We will work closely with [the] FDA on rescheduling the panel meeting and review of the regulatory application.”

The device, invented by Isaac Lipshitz, MD, is designed to be a solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options. Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In that eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision; the non-operated eye provides peripheral vision for mobility and orientation.

After PMA application submission and a July 2006 FDA Ophthalmic Devices Advisory Panel meeting, the FDA issued a letter to VisionCare citing deficiencies in its application that must be addressed before regulatory approval. The issues primarily relate to corneal endothelial cell density and whether cataract removal in patients has a meaningful effect on improvement in visual acuity. In 2007, the company submitted PMA amendments to address the matters identified in the deficiency letter and also responded to additional questions from the FDA.