The FDA usually follows the recommendations of an advisory panel, but is not required to do so. The panel recommended approval of the device with conditions including post-approval surveillance and labeling suggestions. The panel decision was reached by a vote of 8 to 0.
"We are pleased with the panel's recommendation for approval and will work closely with FDA to address the approval conditions," said
Data from clinical studies were presented to the panel by the following leading surgeons and vision experts at the
R. Doyle Stulting, MD, PhD, Professor of Ophthalmology, Director of Cornea Service, Emory University. Stephen Lane, MD, Clinical Professor of Ophthalmology, University of Minnesotaand in private practice at Associated Eye Care, Stillwater, MN. Oliver Schein, MD, MPH, Burton E. Grossman Professor of Ophthalmology, Director of Comprehensive Eye Services at The Wilmer Eye Institute, Johns Hopkins University. Eli Peli, MSc, OD, Senior Scientist and the Moakley Scholar in Aging Eye Research at The Schepens Eye Research Institute, and Professor of Ophthalmology at Harvard Medical School.
End-Stage AMD occurs when the macula in each eye is irreversibly degenerated and no longer provides detailed central vision required for common everyday activities such as recognizing people and facial expressions, or watching television. End-Stage AMD is characterized by central scotomas, or blind spots, in both eyes that cause images in the central visual field to be unrecognizable or not visible at all.
About the Telescope Device
The investigational Implantable Miniature Telescope (IMT(TM) by Dr.
About Macular Degeneration
Macular degeneration is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like recognizing faces and watching television. According to the National Eye Institute over 1.7 million Americans over age 50 suffer mild to profound vision loss from advanced AMD, which frequently culminates as End-Stage AMD (visual impairment due to untreatable advanced AMD). Patients affected in both eyes often experience a loss of independence, social interaction, and have difficulty with activities of daily living requiring detailed vision. Approximately half of the individuals living with advanced AMD are affected in both eyes.
VisionCare Ophthalmic Technologies, Inc., headquartered in
SOURCE VisionCare Ophthalmic Technologies, Inc.