SARATOGA, Calif., May 1 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), announced today two presentations on its platform technology are scheduled at the upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting May 6 - 10, 2007, in Fort Lauderdale, Florida. VisionCare has filed a Premarket Approval (PMA) application amendment for the telescope prosthesis seeking marketing approval for the treatment of central vision loss due to advanced, irreversible forms of AMD.
Presentations are scheduled at the Greater Fort Lauderdale/Broward County Convention Center as follows:
Monday, May 7, 8:30AM - 10:15AM Long-Term Visual Results and Post-Operative Patient Management Factors of a Telescope Prosthesis for End-Stage AMD S.A. Primo, R.D. Stulting, IMT002 Study Group. Emory University Eye Center, Atlanta, GA. Program#/Poster#: 1168/B14 Session Number/Title: 215, Visual Function and Quality of Life I Location: Hall B/C Wednesday, May 9, 3:00PM - 3:15PM Evaluation of End-Stage AMD Implantable Telescope Eyes With Retinal and Anterior Segment OCT H.L. Hudson, IMT002 Study Group. Retina Centers PC, Tucson, AZ. Program#: 4441 Session Number/Title: 464, Retinal Prosthesis Location: Grand Floridian B
About the Telescope Prosthetic Device
The investigational Implantable Miniature Telescope (IMT(TM) by Dr. Isaac Lipshitz) is designed to be a permanent 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. The trial enrolled over 200 patients at 28 leading medical universities and ophthalmic centers across the country. VisionCare has filed a Premarket Approval (PMA) application amendment for the telescope prosthesis. The submission seeks marketing approval for the treatment of central vision loss due to advanced, irreversible forms of AMD. To date, no additional clinical investigations have been requested. Assuming no significant additional analyses or clinical data are required, the Company projects regulatory approval in the second half of 2007.
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.
About VisionCare
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, +1-408-872-9393, mail@visioncareinc.net
Web site: http://www.visioncareinc.net/
