Telescope implant for macular degeneration approved
pharmafile | October 15, 2014 | News story | Medical Communications, Sales and Marketing | FDA, VisionCare Ophthalmic Technologies, macular degeneration, telescope implant
Medical device development firm VisionCare Ophthalmic Technologies has had its implantable miniature telescope for age-related macular degeneration disease approved by the FDA.
The implant was previously permitted for use in patients with end-stage age-related macular degeneration aged 75 years and above, but this expanded indication casts a wider net to include patients aged beyond 65.
The implantable miniature telescope is for use in patients living with bilateral end-stage age-related macular degeneration, and is the only FDA-approved surgical device for end-stage AMD.
It is also ‘Medicare eligible’ in the US, which means any US citizen qualified and enrolled onto its healthcare system can receive it.
FDA approval 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 5 and 8 years, respectively.
“We are pleased and excited about this important FDA decision,” says Allen Hill, president and chief executive of VisionCare. “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 telescope implant is a component of VisionCare’s treatment programme that it calls CentraSight, which is a system to help patients follow the steps necessary for proper diagnosis, surgical evaluation, implantation and postoperative care.
The implant is said to improve 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 the firm says.
“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,” says Dr David Boyer, of Retina Vitreous Associates Medical Group, Beverly Hills, CA.
“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.”
Potential adverse events include decreased vision or vision impairing corneal swelling however, and it should be noted that the device is not a cure for end-stage AMD.
VisionCare points out that 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 is set to increase.
Brett Wells
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