Science Corporation, a leader in brain-computer interface (“BCI”) technology, has announced the preliminary clinical trials results for its PRIMA retinal implant. The patients in the trials had lost their central visual field, which makes them unable to read and struggle to recognize faces. The results showed that the PRIMA implant restored real form vision in these patients such that sequences of letters can be read with a clinically meaningful improvement of letter acuity.

“The results demonstrate a milestone in the treatment of blindness 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 Professor Frank Holz, MD (PDF), scientific coordinator of the PRIMAvera study. “Prior to this, there have been no real treatment options for these patients,” continued Professor Holz, who is Chairman and Professor, Department of Ophthalmology, at the University of Bonn, Germany.

Max Hodak, Science Corp CEO, added: “To my knowledge, this is the first time that restoration of the ability to fluently read has ever been definitively shown in blind patients. 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 study was designed to demonstrate PRIMA’s safety and efficacy to reach European market approval (CE mark). PRIMA, owned and manufactured by Science Corp, is based on original research done at Stanford University and later by Pixium Vision of France.

Clinical Trial of 38 Human Subjects

The PRIMA clinical trial, called PRIMAvera (NCT04676854), is a clinical study with 38 human subjects suffering from geographic atrophy (GA), who were implanted with the PRIMA retinal system to restore vision. Geographic atrophy is an advanced form of dry age-related macular degeneration (AMD) where the central area of the retina, and thus the patient’s sight, has deteriorated.

A Meaningful Improvement of Visual Acuity

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

Preliminary Results

The visual acuity of all participating patients was measured at 6 and 12 months post implantation via logMAR scoring including the use of zoom (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 best patient.
• A success was defined as 10 letters (2 lines) of improvement.
• The mean natural visual acuity (without using PRIMA) remained stable after implantation, which suggests a good safety profile of the PRIMA implant.
• Additional details can be found here (PDF).

The PRIMA System

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

Zoom is an assistive feature of the PRIMA system that changes the size of the features in the image on the retina and implant, but provides a correspondingly smaller field of view.

Additional Background

According to the United States National Institute of Health, there are about one million cases of GA in the US, and about 160,000 new cases occur per year. The American Academy of Ophthalmology estimates that over 8 million people are affected worldwide with GA. The most significant risk factors are increasing age and family history.