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FDA approves device to treat AMD

The US Food and Drug Administration has approved an Implantable Miniature Telescope for patients with age-related macular degeneration

The US Food and Drug Administration (FDA) has cleared for marketing VisionCare Ophthalmic Technologies' Implantable Miniature Telescope (IMT), a first-of-its-kind device intended to improve vision by providing magnification for patients with end-stage age-related macular degeneration (AMD).

AMD, which degrades the retina, affects about eight million older Americans. Currently marketed therapies include Genentech's Lucentis (ranibizumab injection), Pfizer's Macugen (pegaptanib sodium injection) and Novartis' Visudyne (verteporfin). The VisionCare device is the first treatment for AMD patients who have progressed to end-stage disease.

The IMT is a small telescope that is surgically implanted in place of the natural lens of one eye and provides either 2.2 times magnification or 2.7 times magnification, depending on which of two approved models is used. The magnified images are projected onto the part of the retina that is still healthy. The eye without the IMT is used for peripheral vision.

The device has been approved by the FDA for patients aged 75 years or older who have stable, severe-to-profound vision impairment caused by blind spots associated with end-stage AMD and who display evidence of a visually significant cataract.

To be eligible for implantation, patients must complete training with an external telescope first. They must also agree to participate in a post-operative training programme and must sign an Acceptance of Risk and Informed Decision Agreement which states, among other things, that they have been adequately informed about the risk of extensive loss of corneal endothelial cells – a side effect that can damage the cornea.

The IMT was approved based on a 219-patient trial in which 90 per cent of patients had at least a two-line gain in either their distance or best-corrected visual acuity, and 75 per cent of patients improved their level of vision from severe or profound impairment to moderate impairment.

California-based VisionCare must conduct two post-marketing studies: one that will track subjects from its long-term follow-up cohort for an additional two years and another that will enrol 770 new subjects and will include a five-year evaluation of endothelial cell density.

VisionCare said it will sell the device using its new CentraSight Treatment Program, which includes a patient management process and access to reimbursement resources for patients and doctors.

7th July 2010

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