SYLMAR, Calif.—Second Sight Medical Products announced the first successful implantation and activation of a wireless visual cortical stimulator in a human subject, providing the initial human proof of concept for the ongoing development of its Orion I Visual Cortical Prosthesis (Orion I). In the UCLA study supported by Second Sight, a 30-year-old patient was implanted with a wireless multichannel neurostimulation system on the visual cortex and was able to perceive and localize individual phosphenes or spots of light with no significant adverse side effects.

“It is rare that technological development offers such stirring possibilities,” said Robert Greenberg, MD, chairman of the board of Second Sight. “This first human test confirms that we are on the right track with our Orion I program to treat blind patients who cannot benefit from the Argus II Retinal Prosthesis (Argus II). This initial success in a patient is an exciting and important milestone even though it does not yet include a camera.

“By bypassing the optic nerve and directly stimulating the visual cortex, the Orion I has the potential to restore useful vision to patients completely blinded due to virtually any reason, including glaucoma, cancer, diabetic retinopathy or trauma. Today, these individuals have no available therapy and the Orion I offers hope, increasing independence and improving their quality of life.”

Second Sight said that the initial success of the study, coupled with the significant additional pre-clinical work gathered to-date will enable the company to submit an application to the FDA in early 2017 to gain approval for conducting an initial clinical trial of the complete Orion I system, including the camera and glasses. Assuming positive initial results in patients and discussions with regulators, Second Sight plans an expanded pivotal clinical trial for global market approvals.

Jim Little, a Second Sight executive presented the company’s Argus II Retinal Prothesis System at Vision Monday’s 2012 Global Leadership Summit.