November 5, 2008
Long-Term Results of VisionCare’s Implantable Telescope for End-Stage Macular Degeneration Published in the American Journal of Ophthalmology
SARATOGA, Calif., Nov. 5 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), today announced that the American Journal of Ophthalmology (AJO), a premier peer-reviewed medical journal, has published two-year results from the Phase II/III IMT002 trial showing substantial visual acuity improvement in End-Stage AMD patients. The study device, a first-of-kind implantable telescope, has received CE Mark approval in Europe and is currently investigational and under regulatory review by the U.S. Food and Drug Administration.
The publication details the two-year safety profile of the device and found rates of cornea endothelial cell loss, while higher than conventional small-incision anterior segment eye surgery, were consistent with anterior segment procedures employing more similar incision sizes required for telescope implantation.
"The published data show improved visual acuity in end-stage AMD patients that was maintained over two years -- a three-line improvement that we have previously shown makes a real impact on our patients' independence and quality of life," said Henry L. Hudson, M.D., lead author for the IMT002 study and retina specialist at Retina Centers, P.C. in Tucson, AZ. "These findings are important because vision loss from end-stage AMD profoundly affects both the daily activities and social well-being of many older Americans."
"The data presented in AJO confirm the effectiveness of the AMD telescope prosthesis and the long-term safety profile of the device," stated R. Doyle Stulting, M.D., Ph.D., professor of ophthalmology at Emory University in Atlanta and study coauthor. "Key indicators of corneal health and diagnostic verification of device placement substantiate earlier findings that risks of surgery are outweighed by the benefits the improved vision brings to these patients' lives."
"We hope these published results will lead to a new treatment option for patients with end-stage AMD," commented Stephen S. Lane, M.D., the trial's medical monitor who is an adjunct professor of ophthalmology, University of Minnesota, and in private practice at Associated Eye Care, Stillwater, MN. "Across the 28 centers in the study, we were able to provide a novel approach for patients whom we have not had any solutions to improve visual acuity in a functional way."
End-Stage AMD occurs when the macula in each eye is irreversibly degenerated and no longer provides detailed central vision required for common everyday activities such as reading, recognizing people and facial expressions, or watching television. End-Stage AMD is characterized by central scotomas, or blind spots, in both eyes that cause images in the central visual field to be unrecognizable or not visible at all. AMD is the leading cause of irreversible blindness in the United States and other developed countries.
Highlights from the AJO publication on the prospective, multicenter IMT002 study are summarized below.
-- 60% of telescope-implanted study eyes gained 3 lines (15 letters) or more of visual acuity (VA) at 2 years after implantation versus 10% of fellow eye controls (p
-- Study eyes receiving the 3X model telescope prosthesis showed an average VA improvement of 3.6 lines at 2 years compared to 0.5 lines in fellow eye controls (p
-- Median VA improvement was over 3 lines better in telescope-implanted eyes versus corresponding fellow eyes that underwent cataract surgery and intraocular lens implantation (p
-- Loss of 3 lines (15 letters) or more of VA occurred in 0.6% of telescope-implanted eyes versus 7.5% of fellow eye controls (p=0.0013)
-- Corneal endothelial cell loss was 27% two years after surgery, versus 20% through 3 months and 25% through 12 months
"The long-term results described in this publication reflect years of technical and clinical development in collaboration with the IMT002 Study Group investigators," said Allen W. Hill, CEO of VisionCare. "We are pleased the safety and efficacy results of our pivotal clinical trial have been reported in highly regarded scientific journals like the AJO. VisionCare looks forward to successfully completing the U.S. regulatory review process."
The results are published in the November 2008 issue of the AJO and available on-line at the journal's web site http://www.ajo.com/current. Citation: Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE; IMT002 Study Group. Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008: 146; 664-673.
About the Telescope Device
The investigational Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) is designed to be a solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options. Smaller than a pea, the telescope prosthetic device 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 prospective, multicenter IMT002 Phase II/III trial was designed to evaluate the safety and efficacy of VisionCare's investigational medical device in individuals with moderate to profound bilateral central vision impairment associated with End-Stage AMD. A Premarket Approval (PMA) application and subsequent PMA amendments have been submitted to the U.S. Food and Drug Administration and are currently under regulatory review.
About Macular Degeneration
Macular degeneration is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like reading, recognizing faces, and watching television. According to the National Eye Institute over 1.7 million Americans over age 50 suffer mild to profound vision loss from advanced AMD, which frequently culminates as end-stage AMD (visual impairment due to untreatable advanced AMD). Patients affected in both eyes often experience a loss of independence, social interaction, and have difficulty with activities of daily living requiring detailed vision. 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 visual prosthetic devices. The Implantable Miniature Telescope was invented by company founders, Isaac Lipshitz, M.D., and Yossi Gross. Information on VisionCare can be found at http://www.visioncareinc.net/.
VisionCare Ophthalmic Technologies, Inc.
CONTACT: Allen Hill, President and CEO of VisionCare OphthalmicTechnologies, Inc., +1-408-872-9393, [email protected]
Web site: http://www.visioncareinc.net/http://www.ajo.com/current