Approval of device allows eligible patients in Canada new AMD treatment option
SARATOGA, Calif., Nov. 8, 2012 /PRNewswire/ -- VisionCare Ophthalmic Technologies, Inc., developer of the first FDA-approved ophthalmic telescope implant indicated to improve vision in patients with end-stage age-related macular degeneration (AMD), announced today it has received a Health Canada Medical Device License to market the Implantable Miniature Telescope (by Dr. Isaac Lipshitz) in Canada. The telescope implant is an integral component of a new patient care program called CentraSight®, which has been developed to improve vision and quality of life in patients with end-stage age-related macular degeneration (AMD), the most advanced form of AMD. Eligible patients must meet age, vision and cornea health requirements.
The telescope implant offers a new hope to patients living with end-stage AMD. It is the only medical/surgical option that improves visual acuity by reducing the impact of the central vision blind spot caused by end-stage AMD. Smaller than a pea, the telescope implant uses micro-optical technology to magnify images which would normally be seen in one's "straight ahead" or central, vision. The images are projected onto the healthy portion of the retina not affected by the disease, making it possible for patients to see or discern the central vision object of interest.
"The grant of the license from Health Canada to market our implantable telescope in the Canadian market is an important step forward," said Allen W. Hill, VisionCare's CEO. "Our company is moving forward both with the ophthalmic community and reimbursement authorities as we prepare for market introduction. We are excited to have the opportunity to provide this technology and related CentraSight treatment program to patients in Canada living with this devastating disease."
The telescope implant is not a cure for end-stage AMD. As with any medical intervention, potential risks and complications exist with the telescope implant. Possible side effects include decreased vision or vision impairing corneal swelling.
Results from the two U.S. clinical trials, conducted at 28 leading ophthalmic centers, have been published in peer-reviewed scientific journals including Ophthalmology, American Journal of Ophthalmology, and Archives of Ophthalmology. The pivotal clinical trial showed that patients achieved clinically meaningful gains in visual acuity and quality of life with the telescope implant. Most recently, in the September 2011 issue of Ophthalmology, a study reports the intraocular telescope improves quality of life and is also cost effective.
About the CentraSight Treatment Program
The first-of-kind telescope implant is integral to a new patient care program, CentraSight, for patients with end-stage macular degeneration. The CentraSight treatment program involves a patient management process and access to reimbursement information for patients and physicians. The telescope implantation is performed by a specially trained ophthalmic surgeon as an outpatient procedure.
About the Telescope Implant for Canada
The Implantable Miniature Telescope (by Dr. Isaac Lipshitz) is indicated for monocular implantation to improve vision in patients greater than or equal to 65 years of age with stable severe to profound vision impairment (best-corrected distance visual acuity 20/160 to 20/800) caused by bilateral central scotomas (blind areas) associated with end-stage AMD. This level of visual impairment constitutes statutory (legal) blindness.
Smaller than a pea, the telescope 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.
About End-Stage Macular Degeneration
AMD is a disorder of the central retina, or macula, which is responsible for detailed vision that controls important functional visual activities like recognizing faces and watching television. AMD patients often experience a loss of independence and social isolation, and have difficulty with activities of daily living. Approximately half of the individuals living with advanced AMD are affected in both eyes.
VisionCare Ophthalmic Technologies, Inc., headquartered in Saratoga, CA, is a privately-held company focused on development, manufacturing, and marketing of implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. The company's R&D and manufacturing facility is located in Petah Tikva, Israel. VisionCare's investors include Saints Capital, Pitango Venture Capital, Three Arch Partners, ONSET Ventures, BSI Healthcapital, Giza Venture Capital, and Infinity Private Equity Fund. VisionCare's Implantable Miniature Telescope was invented by company founders Yossi Gross and Isaac Lipshitz. Information on VisionCare can be found at www.visioncareinc.net.
SOURCE VisionCare Ophthalmic Technologies, Inc.