First Retinal Prosthesis under FDA Approval
FDA reviewers expressed concern over the long-term safety of what could be the first retinal prosthesis device despite evidence that it helps improve the vision of some nearly blind patients.
Members of the FDA’s Medical Devices Advisory Committee will vote Friday on whether to recommend approval of the Argus II Retinal Prosthesis device. Members of the ophthalmic panel also will discuss and recommend possible post-approval study requirements should the device ultimately gain FDA clearance.
The Argus II is designed for use by patients with severe to profound retinitis pigmentosa, who experience progressive vision loss, often leading to blindness.
