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| An FDA panel will debate the merits of the Argus II on Friday--courtesy of Second Sight Medical Products |
Second Sight Medical Products will make its case before an FDA panel Friday, and a positive recommendation for the Argus II device could lead to the U.S.'s first-approved retinal prosthesis hitting shelves.
First, though, Second Sight will need to address regulators' safety and efficacy concerns. As MedPage Today reports, 19 of the 30 patients examined in the Argus II feasibility study experienced no adverse events, but three of those who did reported retinal detachment and retinoschisis (a splitting of the retina's neurosensory layers).
Also, while the study met most of its secondary endpoints, regulators are concerned that Argus II didn't quite measure up to its goal of helping patients see the orientation of grating bars on squares, according to MedPage Today. Only 8 of the 30 patients were able to do so, and while that's better than those without the device, it falls short of the study's goal.
Already approved in Europe, Argus II consists of a glasses-attached video camera, a wireless processing unit and a corresponding retinal implant. First, the device's miniature camera converts video images into a series of small electrical pulses. Those are then processed and transmitted wirelessly to an implant in the retina, stimulating its remaining cells and allowing the brain to perceive patterns of light. Patients learn over time to interpret those patterns, regaining some functional vision as a result.
The device is designed to treat retinitis pigmentosa, an inherited degenerative disease that affects 100,000 Americans and can result in almost total blindness, Second Sight says.
- read the MedPage Today report
- here's the panel's executive summary (PDF)