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VisionCare Ophthalmic Technologies Inc. announced the FDA approval of the company?s Implantable Miniature Telescope (by Dr. Isaac Lipshitz) to improve vision in patients with end-stage age-related macular degeneration.
Saratoga, CA-VisionCare Ophthalmic Technologies Inc. announced the FDA approval of the company’s Implantable Miniature Telescope (by Dr. Isaac Lipshitz) to improve vision in patients with end-stage age-related macular degeneration (AMD).
The telescope implant is indicated for monocular implantation to improve vision in patients greater than or equal to 75 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 associated with end-stage AMD.
Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In the eye with the implant, 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.
Results from two U.S. clinical trials, conducted at 28 leading ophthalmic centers, have been published in peer-reviewed scientific journals. The pivotal clinical trial showed that patients achieved clinically meaningful gains in visual acuity and quality of life with the telescope implant.
“The published outcomes from these rigorous trials attest to the robust and sustained benefits we were able to attain with the telescope implant for this underserved population,” said Stephen S. Lane, MD, adjunct professor of ophthalmology, University of Minnesota, in private practice at Associated Eye Care, Stillwater, MN, and medical monitor for the telescope implant clinical trials.
“The telescope implant represents a new category of treatment for this severely visually impaired population,” said Allen W. Hill, chief executive officer of VisionCare. “This approval is the culmination of years of scientific and clinical development. We are excited to provide this new technology and related CentraSight treatment program to the ophthalmic community to help their patients with this devastating disease gain improved vision and quality of life.”