News & Publications

VisionCare Begins Enrollment of Implantable Miniature Telescope Pivotal Trial for Macular Degeneration

SARATOGA, CA - January 7, 2003 - VisionCare Ophthalmic Technologies, Inc. (VisionCare), announced today that it has begun enrolling patients in a multi-center Phase II/III clinical trial to assess the safety and efficacy of the company's Implantable Miniature Telescope (IMT™ by: Dr. Isaac Lipshitz). The IMT is being evaluated in patients with moderate to severe bilateral central vision impairment due to either dry or scar-stage wet age-related macular degeneration (AMD) or Stargardt's macular dystrophy. Macular degeneration is the leading cause of irreversible vision loss in individuals over the age of 50. The IMT is a micro-sized precision telescope, about the size of a pea, that is implanted in one eye in an outpatient surgical procedure conducted under local anesthesia. The IMT provides magnification of 3.0X or 2.2X, depending on the IMT model used. A magnified image is projected over a wide field of the retina to improve the ability to recognize images that were previously either difficult or impossible to see. The IMT is implanted in one eye, which provides central vision, while the non-implanted eye provides peripheral vision.

Stephen Lane, M.D., principal investigator at Associated Eye Care, Stillwater, MN who implanted six IMTs in VisionCare's Phase I trial, commented, "We are excited about the potential the IMT provides for improving visual acuity and the quality of life for individuals with severe AMD. We are encouraged with the results produced in the Phase I trial and look forward to studying the IMT in a larger patient population in this Phase II/III evaluation."

"We see many patients in the clinic with advanced AMD for whom we have no real viable treatment options. The IMT technology may give ophthalmologists a method of improving vision and function in the more than 500,000 U.S. patients who have bilateral permanent vision loss due to macular degeneration," said vitreo-retina disease specialist and Phase I investigator, Baruch D. Kuppermann, M.D., Ph.D., University of California, Irvine.

Fourteen patients were implanted with the IMT in the Phase I trial. Patients were monitored for safety and efficacy. One year after implantation, the majority of patients gained three or more lines (a doubling) of distance or near visual acuity and improvement in their activities of daily living. The most common complication was transient inflammation.

IMT Phase II/III Clinical Trial - VisionCare's pivotol clinical trial will enroll approximately 200 patients at up to 30 leading ophthalmic centers in the U.S. To be eligible for participation in the study, patients must have either dry or scar-stage wet AMD or Stargardt's macular dystrophy in both eyes, be 55 years of age or older, with visual acuity not better than 20/80 but not worse than 20/630 in both eyes, and no other major eye disease, except for cataract. Individuals who have undergone surgery for cataracts in both eyes are not eligible for this clinical trial.

For information on the clinical trial, refer to www.visioncareinc.net or call (408) 872-0526.

About Macular Degeneration and Stargardt's Disease
Macular degeneration is a disorder of the retina, the thin light-sensing layer lining the back of the eye. The condition affects the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like reading, recognizing faces, and watching television. Age-related macular degeneration (AMD) is the most common form of the disorder, affecting over 15 million older Americans to some degree. AMD occurs in two forms - "dry" and "wet." Dry AMD accounts for approximately 90% of all cases and results in varying forms of central vision loss, which develop gradually over time. As dry AMD progresses, it may result in scarring of the macula, or geographic atrophy, with associated moderate to severe vision impairment in one or both eyes. Wet AMD accounts for approximately 10% of AMD and is 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 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. is a private, venture capital funded company involved in the research, development, manufacturing, and marketing of innovative and proprietary implantable ocular devices for the treatment of AMD and other vision disorders. VisionCare is headquartered in Saratoga, CA and has research facilities in Yehud, Israel. The IMT was invented by Dr. Isaac Lipshitz and Yossi Gross.

VisionCare Ophthalmic Technologies, Inc. contacts: Allen W. Hill, President & CEO
William (Bill) H. Duffell, Jr., Ph.D., Vice President, Regulatory Affairs and Market Development
Office (408) 872-9393
mail@visioncareinc.net