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

July 6, 2010

Adapted from VisionCare Ophthalmic Technologies, Inc.

VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced the U.S. 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 program, CentraSight, for treating patients with end-stage macular degeneration—the most advanced form of AMD in the U.S. and the leading cause of vision loss 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 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 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.

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.


Read more about the implantable telescope as well as other approved therapies for macular degeneration in our Treatment section.

 

View all news updates for macular degeneration


Disclaimer: The information provided in this section is a public service of the BrightFocus Foundation, and should not in any way substitute for the advice of a qualified healthcare professional, and is not intended to constitute medical advice. Although we take efforts to keep the medical information on our website updated, we cannot guarantee that the information on our website reflects the most up-to-date research. Please consult your physician for personalized medical advice; all medications and supplements should only be taken under medical supervision. BrightFocus Foundation does not endorse any medical product or therapy.

Some of the content in this section is adapted from other sources, which are clearly identified within each individual item of information.

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