National Institute of Health Supports Second Sight with $1.6 Million Grant for Orion Clinical Development

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LOS ANGELES—The National Institute of Health (NIH) is supporting Second Sight Medical Products, Inc. (NASDAQ: EYES), developer and manufacturer of implantable visual prosthetics for the visually impaired, with a $1.6 million grant to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” which began January 2018. According to statements issued by both NIH and Second Sight, the grant will also have an intent to further fund $6.3 million over the next five years and is subject to annual review and approval by the NIH.

“We are delighted to be working with the researchers at the NIH and are deeply appreciative of this grant as we aim to advance Orion and work toward commencing a final clinical study to gain FDA approval. With this grant, we are one step closer to bringing Orion to a broader market that potentially treats a segment of the millions of blind individuals worldwide who have no other option,” stated Will McGuire, president and CEO of Second Sight.

NIH includes 27 Institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency in neuromodulation devices for blindness which conducts basic, clinical and translational medical research. They are committed to developing new technologies to treat the broadest population of sight-impaired individuals, such as Second Sight’s Argus II Retinal Prosthesis System.

Argus II is the only FDA and CE Mark approved device for treating severe blindness due to retinitis pigmentosa (RP), which is a rare inherited genetic disorder that can cause loss of peripheral vision, tunnel vision and blindness. Today, several Argus II devices have been implanted and have been operational in humans for more than 10 years.

The Argus II works in place of lost photoreceptor cells sending electrical pulses to remaining viable retinal cells by converting images captured by a miniature video camera mounted on glasses, which are transmitted to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, enabling perception of patterns of light in the brain. The user learns to interpret these visual patterns in order to regain some visual function.

The company is also in the works of developing the Orion I Visual Cortical Prosthesis which is intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, or forms of cancer and trauma. A feasibility study of the Orion I device is currently underway at the Ronald Reagan UCLA Medical Center in Los Angeles and Baylor College of Medicine in Houston, with expected new studies beginning in 2019.

The NIH grant will fund ongoing and planned clinical activities where five subjects will be implanted with the Orion to evaluate reliability and validate a fitting process.