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 the company’s Orion I Visual Cortical Prosthesis (Orion I), according to a company news release. 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. 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)," Robert Greenberg, MD, PhD, Chairman of the Board of Second Sight, said in the news release. "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.”
“While we still have much work ahead, this successful human proof of concept study gives us renewed energy to move our Orion I development efforts forward,” said Will McGuire, President and CEO at Second Sight. “We believe this technology will ultimately provide a useful form of vision for the nearly 6 million people worldwide who are blind but not a candidate for an Argus II retinal prosthesis. We also remain focused on further developing our Argus II technology for patients with Retinitis Pigmentosa, making it more widely available, and exploring its potential to improve the vision of nearly two million patients blinded by age-related macular degeneration worldwide.”
Nader Pouratian, MD, the UCLA neurosurgeon who performed the surgery, added, “Based on these results, stimulation of the visual cortex has the potential to restore useful vision to the blind, which is important for independence and improving quality of life.”
This implant was performed as part of a proof of concept clinical trial whose purpose is to demonstrate initial safety and feasibility of human visual cortex stimulation. The initial success of this study, coupled with the significant additional pre-clinical work gathered to-date readies Second Sight 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, an expanded pivotal clinical trial for global market approvals is then planned.