Science Corp. Releases Positive Preliminary Study Results for its Retinal Implant

Science Corporation is sharing preliminary clinical trials results showing its PRIMA retina implant restored real “form vision” in patients who had lost their central visual field, allowing them to perform such high acuity tasks as reading or recognizing faces. After receiving a PRIMA implant, patients’ reading ability improved, as they once again could recognize letters.

“The results demonstrate a milestone in the treatment of severe vision loss caused by geographic atrophy due to age-related macular degeneration. For the first time it was possible to restore real form vision in a retina that has deteriorated due to age-related macular degeneration,” said Frank Holz, M.D., PRIMAvera study scientific coordinator and chairman/professor in the Department of Ophthalmology at the University of Bonn, Germany. “Prior to this, there have been no real treatment options to improve vision for these patients.”

The PRIMAvera study is designed to demonstrate PRIMA’s safety and efficacy for European Union market approval (CE mark). PRIMA, owned and manufactured by Science Corp, is based on original research conducted at Stanford University and later by Pixium Vision, which was acquired by Science Corp.

Clinical Trial

Dubbed PRIMAvera, the clinical study involves 38 patients suffering from geographic atrophy (GA) who received the PRIMA retinal system to restore vision. Geographic atrophy is an advanced form of age-related macular degeneration (AMD) where the central area of the retina, and thus the patient’s sight, has deteriorated.

The results show a meaningful improvement of visual acuity when using the system. Patients demonstrated a notable improvement in their letter acuity while using the PRIMA implant to read a series of letters; some study subjects were able to read longer text.

“To my knowledge, this is the first time that restoration of the ability to fluently read has ever been definitively shown in blind patients,” Science Corp. CEO Max Hodak stated. “This represents an enormous turning point for the field, and we’re incredibly excited to bring this important technology to market over the next few years.”

The visual acuity of all participating patients was measured at six and 12 months post implantation via logMAR scoring (zero logMAR indicates normal vision, positive values indicate poor vision), and it demonstrated clinically significant improvement:

• A 23 letter (4.6 lines) mean improvement at 12 months post implantation compared to baseline.
• A 59 letter (11.8 line) maximum improvement in the patient with the best response.
• Success was defined as 10 letters (two lines) of improvement.
• The mean natural visual acuity without using PRIMA remained stable after implantation, which suggests a good safety profile.

The PRIMA system is a visual prosthesis that consists of a photovoltaic implant—totally cableless and autonomous—surgically implanted under the retina, a special pair of glasses with a camera and built-in projection system, and a pocket processor that processes the image for clarity and magnification.

About 1 million GA cases exist in the United States, with roughly 160,000 new cases occurring annually, according to the National Institutes of Health. The American Academy of Ophthalmology estimates that more than 8 million people are affected worldwide with GA. The most significant risk factors are increasing age and family history.

Science Corporation develops brain-computer interface (BCI) technology. The company creates devices aimed at restoring vision, cognition, and mobility. To support progress across the industry, Science Corporation provides components and a vertically integrated infrastructure for others to augment through Science Foundry. The firm is headquartered in Alameda, Calif. and operates facilities in Research Triangle Park, N.C., and Paris, France.