Second Sight Medical (NSDQ:EYES) today said it passed a significant milestone on its quest to treat virtually all forms of blindness, announcing the 1st successful implantation of a mechanical model of its next-generation Orion I device in a pre-clinical study.
Sylmar, Calif.-based Second Sight calls Orion 1 a "visual cortical prosthesis" designed to bypass the eye and the optic nerve using an electrode implanted into the visual cortex of the brain.
It’s based on Second Sight’s Argus II device, which uses an electrode implanted on the surface of the retina. That so-called "bionic eye" won pre-market approval from the FDA back in February 2013 for treating patients with retinitis pigmentosa. The devices work using an eyeglass-mounted camera that wirelessly transmits visual data to the electrode.
Second Sight said the Orion I animal implantation is part of a Phase I trial designed to evaluate fit, form, stability and biocompatibility. Active animal implants are expected to begin by the 1st quarter of 2016 and human clinical work a year later, the company said.
If those studies bear out, an expanded clinical trial is likely, Second Sight said.
"This is a major milestone not only for the company but, more importantly, those affected by virtually all forms of blindness," president & CEO Dr. Robert Greenberg said in prepared remarks. "Following the success of Argus II in patients with retinitis pigmentosa, we are looking forward to extending the hope of restoring some useful vision to nearly all blind individuals with the Orion I."
The Orion I technology could be used to treat patients with nearly all forms of blindness where the optic nerve or retina is completely damaged, including glaucoma, diabetic retinopathy, retinal detachments, trauma or infection, the company said. The company estimates the global population of legally blind people at 6 million.
Second Sight raised $36.2 million in an initial public offering last November.