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

[Patricia A. Lipovsky]

Please see article below.


----- Original Message ----- 
From: "Alan Dicey" <adicey at bellsouth.net>
To: <Undisclosed-Recipient: ;@smtp114.sbc.mail.gq1.yahoo.com>
Sent: Saturday, September 29, 2012 11:23 AM
Subject: [Nfbf-l] FDA panel recommends approval for Second Sight's 
'bioniceye'.


> 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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