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Argus II “Bionic Retina” Receives Recommendation for FDA Approval

Video Included:
Graphic of the Argus II Prosthesis device
You wouldn’t think that the ability to sort black, white and grey socks would be a big deal for a successful attorney, but when that lawyer is completely blind from retinitis pigmentosa (RP), and used a “bionic retina” to accomplish the simple task, well, that is a big deal.

The attorney, Dean Lloyd, was one of six users of the Argus II retinal prosthesis who testified in front of a Food and Drug Administration (FDA) ophthalmic devices panel on September 28. They all urged its members to recommend marketing approval in the U.S. for the device.

I am happy to report that the panel did, in fact, vote to recommend marketing approval, and I think the heartfelt testimonies of those who used the Argus II in clinical trials helped move the panel toward that decision. The panel’s recommendation bodes well for final FDA approval, which will hopefully arrive in the not-too-distant future.

While Dean testified pragmatically — no surprise, he is a lawyer, after all — others who spoke about their experiences with the Argus II were quite emotional. For example, Cathy Blake, also blind from RP, became tearful as she explained how one of the most important benefits of using the Argus II is the ability to see movement.

“What I really love most about the device is I can tell if people walk by me or there are cars moving in the street,” she said. “I was even able to see fireworks — the flashes falling.”

David Brint, a member of the Foundation’s Board of Directors and Science Liaison Committee, spoke compellingly about his son, Alan, a 15-year-old who has very little vision due to Leber congenital amaurosis. David said, “My son can see where there are trees or a sidewalk. He sometimes sees our dogs. But he asked me if he will someday ‘go dark.’ He said he’d be happy if he could just keep what little vision he had. The Argus II might be a way to restore that vision should it be lost later in life.”

Video of the Argus II Retinal Prosthesis, courtesy of Second Sight

Most of the 10-hour hearing focused on safety and efficacy data from the clinical trials. In the morning, both the FDA and Second Sight, developer of the Argus II, presented data. After the patient testimony in the afternoon, the FDA panel had several questions for Second Sight representatives and then deliberated openly among themselves.

FDA approval of the Argus II would be truly historic and groundbreaking. While several clinical trials for potential sight-saving treatments are underway, and Dr. Eliot Berson’s vitamin A regimen for slowing RP is available, there are currently no FDA-approved therapies for rare inherited retinal degenerations.

FDA approval of the device would also be a big boost for Second Sight, which has received marketing approval for the device in Europe and has plans to enhance the Argus II to provide even better vision than it does today.

Right now, the future is looking bright for the Argus II, and I’ll be the first to let you know about the latest developments in the quest to bring it to market.

One Response to 'Argus II “Bionic Retina” Receives Recommendation for FDA Approval'

  1. Romel Sotto says:

    Can this be used by an ROP patient who is totally blind after a laser and a vitrectomy procedures shortly after birth. Thanks.

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