New Telescope Implant for Patients with Macular Degeneration
FDA Approves VisionCare’s Telescope Implant for Macular Degeneration in Patients 65 Years and Older
By Eye² Staff
VisionCare Ophthalmic Technologies, a developer of advanced visual prosthetic devices for the treatment of age-related macular degeneration (AMD), announced earlier this month that the U.S. Food and Drug Administration approved the Implantable Miniature Telescope (by Dr. Isaac Lipshitz) for use in patients living with bilateral end-stage age-related macular degeneration who are age 65 or older. The telescope implant is the only FDA approved surgical device for end-stage AMD and is Medicare eligible.
The telescope implant is the integral component of VisionCare’s comprehensive treatment program called CentraSight, which helps patients follow the steps necessary for proper diagnosis, surgical evaluation, implantation and postoperative care. The telescope implant improves visual acuity and quality of life for suitable patients with AMD whose sight is permanently obstructed by a blind spot in their central vision, making it difficult or impossible to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care. End-stage AMD is uncorrectable by any other treatment including glasses, vitamins, drugs or cataract surgery and is associated with increased stress and depression as vision diminishes.
“We are pleased and excited about this important FDA decision,” said Allen W. Hill, president and CEO, VisionCare Ophthalmic Technologies. “We developed the telescope implant to help older adults who’ve missed seeing moments in their life and lost much of their independence. Now, younger individuals, those age 65 to 74, will also have access to this important therapy for treating end-stage AMD.”
AMD is the leading cause of vision loss in Americans aged 60 and older, affecting an estimated 15 million people. Of those, two million Americans are living with end-stage AMD, and that number will increase as the Baby Boomer generation ages.
The telescope implant was previously approved by the FDA for patients greater than or equal to 75 years of age. FDA approval to expand access to those age 65 and older was based on clinical data provided by the pivotal safety and efficacy study, IMT-002, and long-term studies IMT-002-LTM and IMT-002-LTME, which followed patients to five and eight years, respectively.
The Implantable Miniature Telescope 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.
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