Implantable telescope finally gets FDA approval

VisionCare's implantable telescope for end-stage AMD has finally been given FDA approval. The device, discussed in depth in Ophthalmology Times Europe July 2007, was given CE approval three years ago but has subsequently been undergoing rigorous clinical trials in the United States.The pivotal clinical trial showed that patients achieved clinically meaningful gains in visual acuity and quality of life with the telescope implant.

“The published outcomes from these rigorous trials attest to the robust and sustained benefits we were able to attain with the telescope implant for this underserved population, ” remarked Stephen S. Lane, M.D., Adjunct Professor of Ophthalmology, University of Minnesota, in private practice at Associated Eye Care, Stillwater, MN, and the Medical Monitor for the telescope implant clinical trials.

The telescope implant is designed to improve visual acuity. The magnification provided by the implant reduces the impact of the blind spot caused by end-stage AMD. End-stage AMD causes severe to profound central vision loss in both eyes due to either wet AMD that has progressed to scarring of the macula despite drug treatments, or dry AMD that has progressed to geographic atrophy, the most advanced form of dry AMD.

“The telescope implant represents a new category of treatment for this severely visually impaired population, ” said Allen W. Hill, CEO of VisionCare. “This approval is the culmination of years of scientific and clinical development. We are excited to now provide this new technology and related CentraSight treatment program to the ophthalmic community to help their patients with this devastating disease gain improved vision and quality of life. This day would not be possible without the steadfast commitment of our clinical investigators, employees and venture capital investors. ”

VisionCare will conduct a post-approval study to monitor patient outcomes under commercial conditions. The principal investigator of the study is Oliver D. Schein, M.D., M.P.H., Burton E. Grossman Professor of Ophthalmology at The Wilmer Eye Institute and Professor of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health. A second smaller study will follow clinical trial patients for an additional two years.