VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, announced the US Food and Drug Administration (FDA) has approved the company's Implantable Miniature Telescope (by Dr Isaac Lipshitz) to improve vision in patients with end-stage age-related macular degeneration (AMD). VisionCare's first-of-kind telescope implant is integral to a new patient care programme, CentraSight, for treating patients with end-stage macular degeneration - the most advanced form of AMD in the US and the leading cause of blindness in older Americans.

"This is truly a breakthrough technology for AMD patients as their treatment options have been limited until now," said Kathryn A. Colby, M.D., Ph.D., ophthalmic surgeon at Massachusetts Eye and Ear Infirmary in Boston and an Assistant Professor of Ophthalmology at Harvard Medical School. "The clinical results from the pivotal FDA trial have proven we can place this tiny telescope prosthesis inside the eye to help patients see better and, for some, even to levels at which they can recognize people and facial expressions that they could not before."

"Despite the past decade of advancements in macular degeneration therapies, retina specialists still did not have a treatment for the many wet and dry AMD patients who progressed to end-stage disease," said Julia A. Haller, M.D., Ophthalmologist-in-Chief of the Wills Eye Institute, and Professor and Chair of the Department of Ophthalmology at Jefferson Medical College, Philadelphia, PA. "Starting today, we can provide these patients with new hope."

Results from the two US clinical trials, conducted at 28 leading ophthalmic centres, have been published in peer-reviewed scientific journals including Ophthalmology, American Journal of Ophthalmology, and Archives of Ophthalmology. 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. Endstage 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.

The first-of-kind telescope implant is integral to a new patient care program, CentraSight, for treating patients with end-stage macular degeneration. The CentraSight treatment program involves a patient management process and access to reimbursement resources for patients and physicians. The telescope implantation is performed by a specially trained ophthalmic surgeon as an outpatient procedure.

VisionCare is submitting an application to the Centers of Medicare and Medicaid Services for a new code to establish Medicare beneficiary access to this implantation procedure.

The Implantable Miniature Telescope (by Dr Isaac Lipshitz) is indicated for monocular implantation to improve vision in patients greater than or equal to 75 years of age with stable severe to profound vision impairment (best-corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas (blind areas) associated with end-stage AMD. This level of visual impairment constitutes statutory (legal) blindness.

Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.

AMD 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. The National Eye Institute estimates that over 1.7 million Americans over age 50 suffer vision loss from advanced AMD, which frequently culminates as endstage AMD (visual impairment due to untreatable advanced AMD in both eyes). These - 3 - patients often experience a loss of independence and social isolation, and have difficulty with activities of daily living. Approximately half of the individuals living with advanced AMD are affected in both eyes.

VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA, is a privately-held company focused on development, manufacturing, and marketing of implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders.