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.
