Second Sight Medical Products has completed enrollment of the first Phase of a FDA approved clinical study of the Argus II Retinal Prosthesis System.
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Ten subjects have been recruited for the Phase I trial at four leading ophthalmic centers throughout the US, including Doheny Eye Institute at the University of Southern California (USC), Wilmer Eye Institute at Johns Hopkins University (Baltimore), the University of California at San Francisco, and the Retina Foundation of the Southwest (Dallas). Second Sight will be seeking expansion of the US trial to include other trial sites located in New York, Philadelphia and Atlanta.
This three-year investigational device exemption (IDE) trial is said to be the only long-term study of a retinal prosthesis currently being conducted anywhere in the world. The company also announced that enrollment at key European sites is underway as studies continue in Mexico. The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to retinitis pigmentosa (RP).
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