First Patient Receives FDA-Approved Telescope Implant for End-Stage Macular Degeneration
SARATOGA, Calif., Nov. 10, 2011 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices, today announced that the first patient has received the FDA-approved Implantable Miniature Telescope (by Dr. Isaac Lipshitz) procedure indicated to improve vision in patients with end-stage age-related macular degeneration (AMD). The first patient was evaluated by and received the telescope implant procedure from ophthalmologists Henry L. Hudson, M.D., retinal specialist at Retina Centers, P.C., and Kristin Carter, M.D., anterior segment eye surgeon, both part of the CentraSight™ provider team in Tucson, AZ. The procedure was performed on an outpatient basis at Carondelet Health Network's St. Joseph's Hospital in Tucson.
This first procedure marks the launch of VisionCare's CentraSight treatment program, a new patient care program utilizing the first-of-kind telescope implant for treating patients with the most advanced form of AMD and the leading cause of blindness in older Americans, end-stage AMD. Regional CentraSight Centers of Excellence - multidisciplinary healthcare provider teams trained in patient evaluation, surgical treatment, and visual rehabilitation - are beginning to treat patients this month. Patients and physicians can find more information about the telescope implant and related treatment program at www.CentraSight.com.
"Our patient's procedure is a milestone that brings new hope and a first treatment option for our most visually debilitated AMD patients," said Dr. Hudson, who was a principal investigator in the pivotal trial for FDA approval and lead author of the trial outcomes publications. "Patients with end-stage AMD have been underserved, and they have had limited options until now. Our patients who have exhausted all wet AMD treatment options, or who have the untreatable, advanced form of dry AMD, now have a potential for improved vision and quality of life. We're talking more than just seeing better on the eye chart, but about being more independent in their daily activities and reconnecting with their social network of friends, family, and their community."
"It is really wonderful that the telescope implant is now available," said Dr. Carter, also a clinical investigator during the pivotal trial. "Implanting this micro-optical device so patients can regain many of the visual-related activities they were no longer able to do after losing their central vision can be life-changing for the patient, and is gratifying to me as a surgeon."
Noridian Administrative Services, Medicare's Administrative Contractor for Arizona, was the first Medicare contractor to cover the telescope implant procedure for Medicare beneficiaries visually impaired by end-stage AMD. Other Medicare regional contractors have also begun covering the telescope procedure for eligible patients.
"We are excited to be working with the ophthalmic community to bring the implantable telescope technology to eligible AMD patients living with central blindness," said Allen W. Hill, CEO of VisionCare. "We are grateful to the clinical trial investigators who demonstrated the safety and efficacy of the treatment, and the scientists, our employees, and the array of organizations who have helped bring this treatment to market."
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.
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. Most recently, in September's issue of Ophthalmology, a study reports the intraocular telescope improves quality of life and is cost effective.
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.
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 end-stage 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.
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. The company's R&D and manufacturing facility is located in Petah Tikva, Israel. VisionCare's investors include Saints Capital, Pitango Venture Capital, Three Arch Partners, Onset Ventures, Giza Venture Capital, BSI/Generali, and Infinity Private Equity Fund. VisionCare's Implantable Miniature Telescope was invented by company founders Yossi Gross and Isaac Lipshitz. Information on VisionCare can be found at www.visioncareinc.net.
SOURCE VisionCare Ophthalmic Technologies, Inc.