As the Foundation reported back in February, the Argus II retinal prosthesis, developed by Second Sight Medical Products, received marketing approval from the U.S. Food and Drug Administration.
For those of us on the front lines of fighting blindness — whether we’re raising funds, conducting research or stand to personally benefit from the results — the device’s approval is one of the most exciting milestones in vision restoration ever achieved.
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I am very excited about ProgSTAR, the Foundation’s new study monitoring and documenting the progress of vision loss and retinal changes in people with Stargardt disease. On the surface, the study might not sound very exciting, because it isn’t evaluating a potential cure. However, the information gleaned from ProgSTAR will be of enormous value in designing future clinical trials for Stargardt disease treatments.
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Researchers are developing a number of promising treatment approaches for blinding retinal diseases, which include: correcting genetic defects; replacing lost retinal cells with new ones; and implanting electronic chips, like the recently FDA-approved Argus II. But, sometimes, saving vision simply comes down to keeping retinal cells alive, or at least slowing their degeneration. Known as “neuroprotection,” this approach isn’t just for the retina — it has the potential to preserve and protect all kinds of neural cells, including brain tissue and cells of the central nervous system.
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“Translational research” is the mantra for many of the retinal scientists funded by the Foundation Fighting Blindness. In a nutshell, the phrase refers to the advancement of vision-saving therapies from laboratories into clinical trials and out to the people who need them.
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When it comes to restoring vision in people with retinal diseases, history isn’t made overnight. Treatments and technological advances have to, first, be tested in labs, and then in clinical, or human, trials. And how quickly they move through the process depends on how readily they’re funded, to the tune of tens of millions of dollars. So, making a treatment or device available to the general public takes years, if not decades. Which is why we, at FFB, are so excited about last week’s announcement that the U.S. Food and Drug Administration has granted market approval of the Argus II retinal prosthesis.
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The Argus II Retinal Prosthesis System was recently granted market approval by the U.S. Food and Drug Administration (FDA), which marks a significant milestone in the development of a therapy that has spanned more than 20 years. It was at Johns Hopkins University, in the early 1990s, that I, along with Drs. de Juan, Humayun and Dagnelie, with some early support from FFB, carried out the very first short-term (one hour or so) experiments with human volunteers. We demonstrated that electrical stimulation of the retina could, indeed, produce spots of light perceived by blind patients.
You wouldn’t think that being called an “orphan” is a good thing. But for developers of treatments for rare diseases — including inherited retinal conditions — “orphan” status provides valuable benefits, such as tax incentives, access to special research grants and assistance with clinical trial design. The orphan designation also gives seven years of market exclusivity to the developer of a treatment.
At the Foundation Fighting Blindness, we are always looking forward. Our scientists are continually focused on achieving the next sight-saving breakthrough, and our donors and volunteers are always looking for new opportunities to raise more money to drive the research.
But for a moment, as we put the wraps on 2012, it is very inspiring to look back on the past year and reflect on the many exciting advancements that have been made in our quest for treatments and cures.
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Video Included:
Occasionally, a person losing his or her vision to a retinal degeneration or a family member will ask me about complete eye transplantation. “Why can’t someone just get a new eye?”
Well, we can transplant corneas, the eye’s outer, protective covering. And we can replace lenses clouded by cataracts. (Remarkably, there are about 40,000 corneal transplants and 3 million cataract surgeries in the U.S. every year.)
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Video Included:
When Richard Faubion got the iPhone 4S – the first to include the intelligence software known as the female-voiced Siri – St. Patrick’s Day was coming up. “So I asked Siri to find me an Irish pub,” he recalls. “She told me of 17 locations and provided Yelp reviews, addresses, how far they were. All this came instantly. The things it can find and do – it’s amazing.”
Richard – who has retinitis pigmentosa (RP) and is the Foundation’s Director of Development, West Region – is among a growing legion of visually impaired people turning to the iPhone for assistive technology. To better understand what sets the device apart from others, I spoke with Richard and two other FFB associates affected by retinal diseases to get the skinny on the iPhone, both pros and cons.
Steve is highly respected for his expertise and tireless commitment to finding treatments and cures for vision-robbing retinal diseases. Read More...
As the Foundation's senior science writer, Ben writes science and research articles for the Foundation’s website, newsletters and Eye on the Cure blog. Read More...
As the Foundation's senior writer, Rich writes and edits content for all of the Foundation’s print and online publications, including its blog, Eye on the Cure. Read More...
