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How an FDA-Approved Retinal Prosthesis Came To Be

Image of the Argus II ImplantThe 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.

When the first patient, Harold Churchy, saw two distinct spots of light, I was hooked.  I recall the sheer amazement we all shared in those early days. But if I could go back and talk to my younger, less gray self, I would tell him, ”You ain’t seen nothing yet!”

By 1998, our work had demonstrated that a retinal prosthesis (an implantable long-term device that uses electricity to stimulate the retina) could potentially restore vision in people with advanced retinitis pigmentosa (RP). So I co-founded Second Sight Medical Products, Inc., to develop the prosthesis. In those early days, there were many skeptics, some claiming it could never work because the retina was too sick, others that the technology was not up to the task.

Backed by a small group of devoted investors, we were nevertheless convinced it could be done.  There were plenty of challenges along the way, but, in the end, with more than $200 million in private and public investment, we succeeded.

In 2002, we started our first clincal trial with the Argus I, a 16-electrode implant based on an established cochlear implant platform. We intended to show that we could stimulate the retina for years without damaging it. (There was some fear that continuous electrical stimulation of the retina might ”burn it out.”)

The Argus II Wearable DeviceI recall, vividly, the day we turned on the device in our first patient – and then held our breath as we pointed Harold in the direction of the letter “L” projected on a wall. At first, he said, ”No – nothing, nothing, nothing yet.” And then, ”There’s something! A line… and another line… they look like an ‘L.’”

As much satisfaction as we felt that day, in hindsight, it was just another milestone. We weren’t expecting to show utility with Argus I. But, as it turned out, even with just 16 electrodes (or pixels), the level of vision was useful for our blind volunteers. It helped them navigate, locate objects and, in one case, shoot baskets with a grandson. Patients asked us to commercialize the first implant, but the surgery was too invasive – taking eight hours and requiring an implant behind the ear and in the eye.

In 2007, we began the trial for Argus II, a 60-electrode implant designed from scratch to make it smaller, easier to implant and visually sharper. The study spanned four countries and 30 patients, including 14 in the United States.  We had some adverse events early on, but, thankfully, they were treatable and we learned enough to greatly reduce their occurrence going forward.

I sincerely want to thank all of the patient volunteers from both studies for being incredible pioneers who braved the unknown, with no guarantee of a reward. Without such generous souls, medical science would not be able to advance.

Ultimately, the results of the Argus II trial, which have been published in the journal Ophthalmology, supported market approval in Europe in 2011. In September 2012, an FDA panel of 22 experts voted unanimously in favor of recommending the Argus II for approval, and now the FDA has done so.

With FDA approval, the Second Sight team (now 100 strong) feels a tremendous sense of accomplishment, as if we’ve reached our final destination. But, in fact, it’s just another milestone. Preparing to make the Argus II available in the United States later this year, we continue to improve on the system’s performance and ease of use. The system was designed so that improvements can be achieved through software updates, as with a cell phone or computer.

Twenty-odd years ago, when I embarked on this work to restore vision in blind people, I knew it was a journey that could fill many lifetimes. Although it’s not yet over, we, along with our patient partners and valuable organizations like FFB, are enjoying the journey. Even more important, we are changing the lives of people who previously had no options.

Images courtesy of Second Sight Medical Products, Inc.


30 Responses to 'How an FDA-Approved Retinal Prosthesis Came To Be'

  1. I am interested to learn how to become a participant in these studies. My RP is autosomal recessive, and at 66, my vision still allows me to function. I would be grateful to see how my retina might be saved, rather than waiting until it is gone, and seeing if it can be minimally restored.

  2. Susan Blakely says:

    How will it work for those who are not totally blind, but are considered legally blind?

    • EyeOnTheCure says:

      Susan,
      If you still have some useful vision, even just a little, the prosthesis wouldn’t be appropriate – it is only for people who have bare light perception (or worse).

  3. CONNIE PARRISH says:

    IS THERE ANYTHING BEING DONE TO RESTORE VISION FROM R.O.P.– BLINDNESS FROM LAZER RETINAL SURGERY AT 4MTS OLD . he IS NOW 13 YEARS OLD. BLIND IN LEFT EYE COMPLELY AND LOW VISION IN RT. EYE . RT EYE HAS CATRACT AND DEPOSITS ON IT . VISION IS GETTING WORSE.SEEING CORRECTED IN RT EYE MAYBE 20/80 AT THIS POINT. ANY THOUGHTS OR HELP PLEASE.

    • EyeOnTheCure says:

      Connie, It is important that he be under the care of a good retinal specialist familiar with ROP. The Foundation funds research for inherited retinal diseases – ROP Is not one of the conditions. With that said, some of the research we are funding – stem cells, for example – may someday be beneficial to someone with ROP.

  4. Lakshmanan says:

    Will Argus help the blind with Bardet Biedel Moon Syndrom to regain sight?

    Regards,
    Lakshmanan,India

    • EyeOnTheCure says:

      Lakshmana,

      If the person still has some useful vision, the prosthesis wouldn’t be appropriate – it is only for people who have bare light perception (or worse). If they are blind, it may help someone with BBS. But to confirm that, call the Second Sight Medical Products hotline at 855-756-3703 (toll free) or 818-833-5027 or email patients@2-sight.com. They can give you the most accurate information about the device’s suitability for BBS.

  5. Kathi says:

    This is absolutely incredible! My 23 year old son was diagnosed with RP 2 years ago, and we now feel so hopeful that he will never have to live in the dark. Thank you, thank you, thank you!!!

  6. Donna Frost says:

    As the mother of a 36/yo young lady blinded by RP, I could just sit here, cry and shout at the same time!!!!! I tried for several years to get her in trial tests, but to no avail.

    If I am to understand about this Retional Prostheis, there would have to be an implant? I wasn’t real sure as I read the article. Is there anyway I could get a little more info on how this is all done? Also, I saw just a little about this divise on CBS the other day, and am I correct that it costs $15,000?

    Thank you for anything you can tell us.
    Donna Frost

  7. Linda Nissen says:

    Is Argus II something that will help people with Leber’s amaurosis of the retina?

    And what is the latest research/help for Leber’s amaurosis of the retina?

    Thank you. Linda

  8. Linda Nissen says:

    What is being developed to help people with Leber’s amaurosis of the retina?

    • EyeOnTheCure says:

      Thanks for your comment Linda,

      There are some emerging treatments that may benefit people with LCA. Gene therapy for people with LCA caused by RPE65 mutations is performing well in clinical trials. Gene therapies for other forms of LCA are moving toward clinical trials. At this stage, it is important to get genetic testing to determine what gene is linked to the disease – that will help determine which therapies are most appropriate. Information on genetic testing is on our Web site. (www.fightblindness.org)

  9. NELDA KAY KERN says:

    my Son haS maJor RetIna PRoBLemS
    ThIS ReSeach Is wonaerFUL neWS,

  10. anjum says:

    suffering from disc pallor in both eyes
    high myopia optic atrophy in both eyes
    cornea shows few spk`s both eyes
    ext of resi vision r.e 6/152 and l.e 6/144
    unable to walk freely right left not visible
    using contact lense

  11. anjum says:

    retina detachement .
    r.e 6/152
    l.e6/144

  12. shabir shah says:

    I sincerely want to thank u for this achievement,pl help me, as my father n brother is suffering from RP

  13. Harold M. Taylor, Jr says:

    I have had RP for more than 20yrs now and I’m 49 and had to give up a lot in my life the one thing I love doing: Driving,Boating and being independent. I’m so so glad for Argus 2 now We have hope!!! I can start dreaming again and this time it will turn into REALITY!! Yippee!!

  14. Mansel Rajaharam says:

    Great News, all I can say is Thank God.

  15. C.J. CARE says:

    I was made aware of Second Sight Medical with the “He, Robot” article in TIME Magazine, Feb. 25,2013. Any mention of the word “retina” seals my attention as my (grown) son was born with retinal colobomas in both eyes and is legally blind. I see that the Argus II has no application to him; but, I heartily commend all your efforts in seeking remediation of the blindness of eye diseases. I would be most interested in any information with regard to future research or development in the field of retinal colobomas! You, most assuredly, have made and are making meaningful contributions to our world. Thank you.

  16. Rahul says:

    I have a 1 question, which my father have a blindness since last 25 years.He is completely living his life in a dark & I don’t want to place him in a dark. At the time of operation Dr. told us that the blood vessels which carries blood from brain to eyes have damaged(bursts) so no need to do operation it won’t be success.
    But now i have hopes due to the technology he can see the world.
    So now i want to ask you 1 Que. is that can he able to see world with Argus||?

    waiting for your reply.

    • EyeOnTheCure says:

      Rahul,

      For the Argus II to potentially work, the patient needs to have a functional optic nerve which carries electrical signals from the retina to the brain. Based on your description of what has happened to your father, it sounds like there may be an issue with the optic nerve. Also, keep in mind that the Argus II is only for people with advanced retinitis pigmentosa (or like conditions) at the moment. For more information on the Argus II and if it may be appropriate for your father, contact Second Sight Medical Products at 1-855-756-3703.

  17. Carol Camm says:

    My Husband, Tom, has lost his vision in one eye totally and has 2200 vision in the other eye. After numerous lasers and retina detachment surgies nothing can be done for the one eye. We are very disappointed that nothing can be done. This happened in 2009 when my husband, Tom’s diagnosis was not done right and it took 2 months for them to find out his gall bladder was bad causing his sugar and other problems leading to retina detachments in both eyes during this time. Previous to this he had very good vision. Now it is devastating what has happened. The wrong diagnosis can damage your life as was his case and he is now surviving through the bad experience. Is there anything that can be done for the blind eye?

    • EyeOnTheCure says:

      Hi carol,

      It is difficult to answer the question without knowing specifically what happened to the eye, retina, and optic nerve. It may be that a future stem cell treatment may restore vision. Perhaps an artificial retina would help, though they are currently only for people with retinitis pigmentosa. If the optic nerve is damaged – that is a more difficult problem to resolve. It is important for your husband to get a good clinical analysis to understand what future therapies might or might not help. Seeing a retinal specialist would be a good course of action.

  18. sonal says:

    I hope the day will come when ARGUS will enhance more electrodes so that persons suffering from RP will be able to visualize the world like a normal person.I would like to thank the researchers engaged in the study and appeal to them to expedite the process as it is the only hope for persons suffering from RP and blindness.

  19. Manal says:

    My daughter 20 year old had stargardt there is any hope for her

  20. Aileen Vergara says:

    Good day!Is ARGUS II available now here in the philippines ? how much would be the cost? Because my mother has a RP also it affects her both eyes. I hope that you can send me the details for my question. thanks a lot :)

    • EyeOnTheCure says:

      Aileen, Thanks for your comment

      For more information on the Argus II and if it may be an option for you as well as where it may be available, we recommend that you contact their Second Sight Medical Products hotline at 1-855-756-3703.

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