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April 24th Meeting of Ophthalmic Devices Advisory Panel PostponedHad Been Scheduled to Discuss VisionCare's Implantable Telescope to Improve Visual Acuity in Patients with End-Stage Macular Degeneration Saratoga, CA - April 22, 2008 - VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), today announced that the review of the investigational Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) by the FDA Ophthalmic Devices Advisory Panel, originally scheduled for April 24, has been postponed. VisionCare requested and was granted a postponement of the meeting to allow time for submission of additional long-term clinical data and review of data by FDA. "VisionCare will be submitting additional data to FDA that we believe will be helpful in completing the review and regulatory approval determination regarding the company's Premarket Approval application for our implantable telescope," said Allen W. Hill, CEO of VisionCare. "We will work closely with FDA on rescheduling the panel meeting and review of the regulatory application." About the Telescope Device The investigational Implantable Miniature Telescope (IMT™ 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. Based on data included in the published results and from ongoing patient follow-up, VisionCare filed a Premarket Approval (PMA) application for the telescope prosthesis. The PMA submission sought market approval for the treatment of central vision loss due to advanced, irreversible forms of AMD. Subsequent to a July 2006 FDA Ophthalmic Devices Advisory Panel meeting, FDA issued a letter to VisionCare citing deficiencies in the application that must be addressed to place the regulatory submission in approvable form. The issues primarily relate to corneal endothelial cell density and whether cataract removal in these subjects has a meaningful effect on improvement in visual acuity. PMA amendments were submitted to FDA in 2007 addressing the matters identified in the deficiency letter, as well as providing responses to additional questions and inquiries presented by FDA. 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 www.visioncareinc.net.
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Caution: Investigational Device, Limited by Federal Law to Investigational Use. |