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VisionCare Completes Enrollment of Macular Degeneration Phase II/III Pivotal Trial - Milestones Trigger Completion of Financing RoundSaratoga, CA - October 31, 2003 - 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 completion of patient enrollment into its Phase II/III clinical trial for untreatable late-stage AMD. VisionCare also announced the completion of the second tranche of its Series C Preferred Stock financing, raising $12.4 million from its investors, including Onset Ventures, Three Arch Partners, Pitango Venture Capital, and Infinity Venture Capital, in addition to the $6.8M invested in July 2002. The funds raised will be used for clinical investigations, product development, and commercialization planning. VisionCare's IMT-002 trial is assessing the safety and efficacy of the Company's recently developed Wide Angle (WA) Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) in individuals with moderate to severe bilateral central vision impairment associated with late-stage dry or scar-stage wet AMD, or Stargardt's macular dystrophy. The tiny device, smaller than a pea, is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the WA IMT 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 navigation. "We are very pleased to have reached these important clinical and financial milestones on schedule," said VisionCare's President and Chief Executive Office, Allen W. Hill. "The high level of interest and enthusiasm among the investigational sites, physicians, and patients participating in the IMT-002 trial has been gratifying. With their help, we are one step closer to providing a solution for this untreatable sight-depriving disease." The pivotal trial, which commenced earlier this year, is being conducted at 28 leading ophthalmic centers across the U.S. and enrolled over 200 study patients with late-stage AMD who met the trial criteria. Patients will be followed up one year for efficacy (visual acuity), and an additional year for safety. About Macular Degeneration and Stargardt's Macular Dystrophy AMD occurs in two forms - "dry" and "wet." Dry AMD results in varying levels of central vision impairment, which develops gradually over time. As dry AMD progresses to its late stage, it may result in scarring of the macula, or geographic atrophy, with associated irreversible, moderate to severe vision loss in one or both eyes. Wet AMD is 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, 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. |