VisionCare Ophthalmic Technologies has received approval from the US Food and Drug Administration for its Implantable Miniature Telescope.
The approval has been granted for the surgical device to use in patients living with bilateral end-stage age-related macular degeneration (AMD) who are aged 65 or older.
VisionCare Ophthalmic Technologies president and CEO Allen Hill said the company developed the telescope implant to help older adults, who have 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," Hill added.
The approval was based on pivotal safety and efficacy study, IMT-002, and long-term studies IMT-002-LTM and IMT-002-LTME, which followed patients to 5 and 8 years, respectively.
Implantable Miniature Telescope is said to improve visual acuity in patients with AMD whose sight is permanently obstructed by a blind spot in their central vision.
The blind spot in central vision makes difficult to see faces, read, and perform everyday activities such as watching TV, preparing meals, and self-care.
Earlier, the telescope implant received FDA approval to treat patients greater than or equal to 75 years of age.
VisionCare said that 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.
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.