FDA Approval Given of First-Ever Implantable Telescope for End-Stage Macular Degeneration

September 10, 2010

The newly FDA-approved telescope will give hope to patients with end-stage Macular Degeneration.

Telescope Implant to be used to treat the leading cause of blindness in older Americans

Dr. Akamine Davidson is pleased to announce that the U.S. Food and Drug Administration approved an Implantable Miniature Telescope to improve vision in patients with end-stage, age-related macular degeneration (AMD). The first-of-its-kind telescope, the implant was developed by Dr. Isaac Lipshitz of VisionCare and is sure to be an integral part of new patient care referral programs for the patients of Dr. Akamine Davidson at her Riverside, California optometry practice. End-stage Macular Degeneration is the most advanced form of AMD in the U.S. and is the leading cause of blindness in older Americans and a specialty of Dr. Akamine Davidson.

“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 U.S. clinical trials, conducted at 28 leading ophthalmic centers, 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 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.

CentraSight Treatment Program
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.

Patients and physicians can find more information about the telescope implant and related treatment program at www.centrasight.com.

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.

About the Telescope Implant
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.

The risks and benefits associated with the telescope implant are discussed in the Patient Information Booklet available at www.centrasight.com.

About End-Stage Macular Degeneration
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 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.

If you suspect that you may have age-related Macular Degeneration, call Dr. Akamine Davidson today to schedule an appointment today 951-784-2420. Her Riverside optometry office is comfortable. She and her staff members are friendly and knowledgeable. And her designer eyewear collection is impressive.

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