Second Sight (Sylmar, California) is working on the second generation of an implantable device – an artificial retina – that it believes will help people, struck by blindness due to retinal degenerative diseases, to see again.

Six people already have been implanted with the first generation of the device, which employs 16 pixels, and Second Sight expects to implant the second generation, a 60-pixel device, within six months.

“Our first generation only had 16 pixels – 16 spots of light – which was really done just as an experiment, but it turned out that even by scanning, the patients could use the 16-pixels to find objects – to tell the difference between objects and so on,” Second Sight President and CEO Robert Greenberg, MD, PhD, told Medical Device Daily.

The artificial retina works by acquiring power and data from external electronic devices that electrically stimulate the retina through an array of electrodes.

“The way this device works is you have a video camera that sends input to electrodes that are on the back of the eye – the retina – so the number of electrodes correlates to the number of pixels, or spots, of light that the patient sees,” Greenberg said. “So, just like pixels on your [computer] monitor, or lights on a scoreboard, the more you have, the finer the resolution of the image.”

Greenberg said he expects the second generation of the artificial retina to provide “enough useful vision” to be the company’s first commercial product. And while pricing has not been set, the most comparable product is cochlear implants, which cost about $25,000.

However, Greenberg said the artificial retina is still more complex than the cochlear implant and would likely cost more.

As to whether or not Second Sight will be able to commercialize the product on its own or would have to partner, he said, “Right now both options seem possible.”

Second Sight has the regulatory and manufacturing expertise in-house, but it doesn’t have a sales force. Greenberg said the company is considering both alternatives now.

Although Second Sight is developing the prosthesis, it is partnered with a number of other organizations. The actual implantations took place at the Doheny Eye Institute of the University of Southern California (USC; Los Angeles).

Others involved in the project include the Salk Institute (San Diego); University of California at Los Angeles; University of California, Santa Cruz; University of California at Berkeley; the Alfred E. Mann Foundation (Valencia, California); Advanced Bionics (also Valencia); and several national laboratories, including the Department of Energy’s (DOE) Argonne National Laboratory (Argonne, Illinois). The project involves collaboration with the Oak Ridge National Laboratory in Tennessee; Lawrence Livermore in California and Los Alamos in New Mexico.

In October, Second Sight and the DOE announced a collaborative research and development agreement. The DOE is funding the project at $20 million over the next three years.

At the time, Argonne’s director of technology transfer, Stephen Ban, said, “Harnessing the intellectual power of five national laboratories and two other institutions presents a promising way to solve huge problems . . . however, it brings with it an additional degree of complexity and a need for close communication between key researchers.”

At Argonne, a company has been formed based on the technology developed there by materials scientist Orlando Auciello, Argonne’s principal investigator, and his colleague, physicist John Carlisle. Auciello and Carlisle created an application for the patented ultrananocrystalline diamond technology developed at Argonne for the packaging of implantable electronics and as electrode material.

Argonne said the scientific and technological bases of ultrananocrystalline diamond films were developed by a large group of researchers in the Surface Science group in Argonne’s Materials Science Division.

However, the artificial retina research began with Mark Humayun when he was at Johns Hopkins University (Baltimore). He is now at the Doheny Eye Institute.

Carlisle told MDD that he and Auciello were giving a talk in Los Angeles about five years ago when someone affiliated with Second Sight heard the presentation and told them afterward the company was looking for “a film technology that could be used in two applications specific to the retinal prosthesis.”

“One is a hermetic coating, a biocompatible hermetic coating [that] would be placed around the silicon microchip that’s going to be implanted in the eye,” Carlisle said. “The second thing was the electrodes, [i.e.] the electrodes that stimulate the retina.”