VisionCare Ophthalmic Technologies, a developer of advanced visual prosthetic medical devices, has received FDA approval for its Implantable Miniature Telescope to improve vision in patients with end-stage age-related macular degeneration (AMD).
VisionCare’s telescope implant is integral to a new patient care program, CentraSight, for treating patients with end-stage macular degeneration, the advanced form of AMD in the US and the leading cause of blindness in older Americans.
VisionCare said that the results from the two US 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.
The telescope implant has been designed to improve visual acuity. The magnification provided by the implant reduces the impact of the blind spot caused by end-stage AMD.
VisionCare is expecting to conduct a post-approval study to monitor patient outcomes under commercial conditions. A second smaller study will follow clinical trial patients for an additional two years.
Allen Hill, CEO of VisionCare, said: “The telescope implant represents a new category of treatment for this severely visually impaired population. 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. This day would not be possible without the steadfast commitment of our clinical investigators, employees, and venture capital investors.”