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VisionCare Announces Upcoming Macular Degeneration Clinical Trial Presentations at American Academy of Ophthalmology MeetingPhase II/III trial completes one-year follow-up Saratoga, CA - October 19, 2004 - VisionCare Ophthalmic Technologies, Inc., focused on the development of proprietary visual prosthetic devices for the treatment of age-related macular degeneration (AMD) and other central vision disorders, announced today the following presentations are scheduled at the upcoming Joint Meeting of the American Academy of Ophthalmology (AAO) and the European Society of Ophthalmology (SOE) in New Orleans, LA, October 23-26, 2004. The three oral presentations include interim Phase II/III and final Phase I data presentations from VisionCare's prospective, multicenter macular degeneration clinical trials of the Implantable Miniature Telescope (IMT by: Dr. Isaac Lipshitz). Phase II/III 6-month interim data paper presentations: *Retina focus presentation in the Retina/Vitreous Free Paper session Final Phase I results from American Journal of Ophthalmology publication: VisionCare also announced that the Phase II/III trial one-year follow-up, required for the visual acuity efficacy endpoint, has been completed. The Company plans to file a Premarket Approval (PMA) application for its investigational visual prosthetic device with the FDA in the first half of 2005. "We are very pleased with the progress of the pivotal trial of our telescope implant for the treatment of moderate to profound visual impairment in individuals suffering from end-stage AMD," commented Allen W. Hill, VisionCare's President and CEO. "Our investigational sites have done a first-class job executing the trial on this novel device, and we look forward to submitting our request for regulatory approval." In October 2003, VisionCare completed patient enrollment of 218 patients at over 25 leading medical universities and ophthalmic centers into its US Phase II/III pivotal trial for untreatable late-stage AMD (end-stage AMD) and Stargardt's macular dystrophy. The ongoing Phase II/III trial is assessing the safety and efficacy of its recently developed wide angle telescope implant in individuals with moderate to profound bilateral central vision impairment associated with end-stage AMD. Phase I trial results demonstrated that one year after implantation, 77% (10/13) of patients gained two or more lines of distance or near visual acuity and 62% (8/13) of patients gained three or more lines (a doubling) of visual acuity as measured on a standard (ETDRS) eye chart. The most common complication was transient inflammation. The telescope implant is a visual prosthetic device designed to be a permanent solution for moderate to profound vision loss due to macular degeneration. Smaller than a pea, this 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 help improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation. About Macular Degeneration AMD occurs in two forms, "dry" and "wet," both of which result in end-stage AMD. Dry AMD results in varying levels of central vision impairment, which develops gradually over time. As dry AMD progresses to its end stage, it results in irreversible deterioration of the macula, or geographic atrophy, with associated irreversible visual impairment in one or both eyes. Wet AMD is also a late stage of the disease, caused by the growth of abnormal blood vessels under the macula. It can cause rapid central vision loss and may eventually lead to a disciform scar (end-stage wet AMD), resulting in a permanent loss of central vision in one or both eyes. Stargardt's disease, a less common type of macular degeneration, typically surfaces before the age of 20. This disease causes a progressive loss of central vision in both eyes, but does not affect peripheral vision. About VisionCare Contact: |
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Caution: Investigational Device, Limited by Federal Law to Investigational Use. |