[Nfbf-l] Follow-up article: US follows Europe Positive FDA panel advice on Argus II

[Alan Dicey]

Dear Friends,

I am just passing this on, it is in regards to the news article I sent you a 
couple of days ago.

It seems to be off a list I am not on, so I do not have any information 
about it's author, but it is a great article and wonderful news to many of 
us.

With Best Regards,

Alan

Miami, Florida



 Dear all
Yesterday was an important day, for me and possibly for some of you in the 
future.
In the fall of 1991, in an operating room of the Wilmer Eye Institute at 
Johns Hopkins, a courageous volunteer blind from RP agreed to undergo a test 
in which the retina was stimulated with a small electrical current -- and 
the volunteer told us he saw flashes of light.

Yesterday, in front of a panel of 21 experts, 4 participants in the Argus 1 
and Argus II trials, and 2 European Arus II recipients in taped 
testimonials, explained how a retinal implant has changed their lives.

Those accounts, more than any of the information on safety and probable 
benefit (the two criteria for recognition as a Humanitarian Use Device, may 
have swayed the panel.  Whether they did or not, after a long day of 
presentations and deliberations, the panel members (even though two had 
misgivings about the safety, and one about the strength of the benefit) 
unanimously voted that the probable benefit outweighs the risk.  This paves 
the way for the FDA to start formulating the conditions for marketing, and 
for Second Sight to start negotiating with Medicare and private insurers to 
get coverage for the Argus II.

Don't expect retinal surgeons everywhere in the US to start doing implants 
in the next few months, though.  Even if everything goes smoothly, and 
commercial implants can start by next spring, they will all be under 
supervision of local Institutional Review Boards, and each participating 
center will have to meet rigorous standards, not just in terms of surgical 
capabilities, but also in guaranteeing the participation of specially 
trained low vision rehabilitation specialists.  The developments in Europe 
are a good example:  18 months after obtaining marketing approval there, 
Second Sight has partnered with 5 centers (1 in Italy, the other 4 in 
Germany), and just 11 patients have received implants).  But more centers 
are coming on line, and quite a few patients are waiting to hear when it 
will be their turn.

It took Second Sight 13 years and about $200 Million (half of it in private 
investments, the other half in grants) to get to this point.  Other groups 
(especially in Germany and Australia) have performed human implants and are 
likely to get market approval in the next few years.  An the quality, both 
of the implants and of the vision they convey, will improve.

Four people present at yesterday's panel meeting have vivid memories of that 
day in the Wilmer operating room: .Eugene de Juan, the retinal surgeon; Mark 
Humayun, then an ophthalmology resident, now also a retinal surgeon; Robert 
Greenberg, then a graduate student, now the CEO of Second Sight; and me, 
still at Wilmer.  Hearing the patients' testimonials, and hearing the votes 
read out at the end of the day, are sure to be vivid memories for us for a 
long time.

I hope that many of you will see the fruits of what happened yesterday.

Gislin
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