[Nfbf-l] FDA panel recommends approval for Second Sight's 'bionic eye'.

[Alan Dicey]

FDA panel recommends approval for Second Sight's 'bionic eye'.
September 28, 2012 by MassDevice staff.
A FDA advisory panel recommends that the federal watchdog agency approve a 
humanitarian device exemption for Second Sight's Argus II "bionic eye" 
retinal implant.
A 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.

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.

"While there are concerns regarding the safety profile based on premarket 
data, there is also concern about the possibility that the frequency of 
adverse  events could increase over time and/or the events could worsen in 
severity" according to panel documents

Second Sight is seeking humanitarian device exemption for the Argus II 
system in patients aged 25 and older who have severe to profound retinitis 
pigmentosa, experience bare or no light perception in both eyes and have 
"previous  history of useful form vision."

The FDA's HDE approval system is designed to incentivize development in 
devices that treat conditions affecting 4,000 or fewer people in the U.S. 
each year.
The application system is similar to the pre-market approval process with 
the exception that the device maker isn't held to the same efficacy 
standards as long as the device can demonstrate safety.

The implant, which may be surgically place in one or both eyes, includes an 
antenna, an electronics case and an electrode array, according to the 
company's website. The external equipment includes glasses, a video 
processing unit  and a cable.

Should Argus II win FDA approval, it will be the 1st retinal prosthesis on 
the U.S. market, according to panel documents.

The panel will also consider whether clinical studies for the Argus II are 
enough to demonstrate safety and efficacy. Second Sight conducted a study 
involving 30 patients who were implanted with 2 different device 
configurations, neither of which match the version of the device being 
considered for market approval.

In addition, the study was non-randomized, researchers were un-blinded and 
"numerous modifications" were made during the course of the trial, according 
to a note to panelists.

The Argus II won CE Mark approval in the European Union last year. The 
device is also in the midst of a 3-year U.S. clinical trial, expected to 
enroll 30 patients and close in July 2014, according to regulatory filings.

Source URL:
https://www.massdevice.com/news/fda-panel-recommends-approval-second-sights-bionic-eye?page=show

The September 28 FDA Executive Summary on Argus II Retinal Prosthesis System
is available at the PDF file URL

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OphthalmicDevicesPanel/UCM320777.pdf

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