FDA panel recommends approval for Second Sight's 'bionic eye'

September 28, 2012 by MassDevice staff

FDA advisory panel recommends that the federal watchdog agency approve a humanitarian device exemption for Second Sight's Argus II "bionic eye" retinal implant.

Second Sight's Argus II retinal implant

An FDA advisory panel recommended approval for a "bionic eye" designed to restore sight for the blind.

The FDA's Ophthalmic Devices Panel voted 17-2 that the Argus II device's benefits outweigh any potential risks; 18-1 that a clinical trial demonstrated "a reasonable assurance of safety;" and was unanimously agreed that the proposed minimum age requirement of 25 years is appropriate.

The "bionic eye," which uses a head-worn camera to capture a scene and process it into electrical signals that are then sent to the cells in the eye, may pose long-term risks that increase over time, according to panel documents released ahead of the meeting. Nevertheless, the panel agreed that the federal watchdog agency ought to grant a humanitarian device exemption for the Argus II retinal prosthesis.

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The FDA is not obliged to abide by the panel's ruling, but usually follows its advisory boards' recommendations.

In a small study conducted in support of the FDA application, 30% of Argus II recipients required multiple revision surgeries to manage adverse events more than 2.5 years after the procedure. More than 40% experienced non-serious "fibrotic events," which include retinal detachment and retinal tears, and 10% suffered serious fibrotic events.