US-based developer of advanced visual prosthetic devices VisionCare Ophthalmic Technologies has received US Food and Drug Administration (FDA) approval for its implantable miniature telescope.
The surgical device is designed for use in patients living with bilateral end-stage, age-related macular degeneration (AMD) who are aged over 65.
The company said the telescope implant is the only FDA-approved surgical device for end-stage AMD and is eligible for Medicare.
The telescope implant is the integral component of the company’s comprehensive treatment programme called CentraSight, which helps patients follow the steps necessary for proper diagnosis, surgical evaluation, implantation and post-operative care.
Retina Vitreous Associates Medical Group Dr David Boyer said: "Despite all the great pharmacotherapy advances in AMD treatment, some patients will unfortunately progress to end-stage AMD where their straight ahead, central vision is permanently blocked.
"Once end-stage AMD patients have lost their central vision, cataract surgery will not provide them with as much benefit to their quality of life as the telescope implant."
The approval was based on data from the 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.
VisionCare Ophthalmic Technologies CEO Allen Hill said: "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."
The company said the telescope implant improves visual acuity in patients with AMD whose sight is permanently obstructed by a blind spot in their central vision.
Their blind spot in central vision makes it difficult to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care.
Earlier this year, the telescope implant received FDA approval to treat patients aged 75 and over.
VisionCare said 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 the quality of vision diminishes.
Image: The telescope implant uses wide-angle micro-optics to improve vision for patients with end-stage AMD. Photo: courtesy of PRNewsFoto/VisionCare Ophthalmic Technologies.