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Phase I Results of Visioncare's Implantable Miniature Telescope For Macular Degeneration Presented at ARVOSaratoga, CA - May 8, 2003 - Positive Phase I clinical trial results were reported today for the Implantable Miniature Telescope, a telephoto ocular prosthesis designed to improve impaired central vision in patients with macular degeneration, a disease of the central retina. The results, based on twelve-month clinical data, were presented in the Retinal Prosthesis session at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida, by M. Bowes Hamill, M.D., a Phase I clinical investigator at the Cullen Eye Institute, Baylor College of Medicine, Houston, TX. In the Phase I U.S. IMT-001 trial, sponsored by VisionCare Ophthalmic Technologies, Inc. (VisionCare), the Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz) was evaluated in patients with moderate to severe bilateral central vision impairment due to either dry or scar-stage wet age-related macular degeneration (AMD). AMD is the leading cause of irreversible vision loss in individuals over the age of 50. The clinical data, presented by Dr. Hamill, included fourteen patients that were implanted with the IMT at four investigational sites. Trial participants were 60 years of age or older, had bilateral geographic atrophy (dry) or disciform scar (scar-stage wet) AMD and visual acuity no better than 20/80, but no worse than 20/400. The IMT was implanted in the poorer seeing eye, and patients were monitored for safety and efficacy. One year after implantation, 77% of patients gained two or more lines of distance or near visual acuity and 62% percent of patients gained three or more lines (a doubling) of visual acuity. Patients gaining two or three lines of distance or near visual acuity reported a 29% or 55% gain, respectively, in activities of daily living (ADL) scores. The most common complication was transient inflammation. These positive results supported the expansion of the clinical investigation to a Phase II/III pivotal clinical trial, which is now underway. "The preliminary safety and efficacy data from this trial are encouraging," said Dr. Hamill. "We are pleased with the safety profile in this pilot study, including the preservation of critical ocular structures during and after implantation of the IMT. We are hopeful that both the safety performance and patient benefits seen in this study will be confirmed in the larger Phase II/III trial which is currently enrolling patients." "These results are promising, and with further study, we may finally have a treatment option that can permanently improve vision in patients with stable, late-stage macular degeneration," commented Baruch D. Kuppermann, M.D., Ph.D., retina specialist at the University of California, Irvine, and an IMT-001 investigator. "The loss of central vision caused by this debilitating retinal disease can severely affect one's ability to perform everyday activities. Although not curative, these results offer hope of enhanced central vision for the large population afflicted with macular degeneration." The abstract for the presentation can be accessed at the ARVO website at www.arvo.org (Program #4209). About the IMT About the IMT Phase II/III Clinical Trial For information on the clinical trial, please refer to www.visioncareinc.net or call 1-(888) 528-0006. About Macular Degeneration and Stargardt's Disease 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 central part of the retina. 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 VisionCare Ophthalmic Technologies, Inc. contacts: |
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Caution: Investigational Device, Limited by Federal Law to Investigational Use. |