Science Corporation has announced positive preliminary results from a European clinical trial of its PRIMA retina implant, which is designed to restore vision in patients suffering from geographic atrophy. The brain-computer interface technology restored “form vision” in patients who had lost their central visual field, allowing them to perform tasks such as reading and recognizing faces.
The PRIMAvera pivotal trial in the European Union and United Kingdom (NCT04676854) involved 38 patients implanted with the PRIMA retinal system, a wireless photovoltaic device surgically placed under the retina (Figure 1). Patients wear a special pair of glasses with a camera and built-in projection system and carry a pocket-sized device that processes the image for clarity and magnification.
Figure 1. 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 built-in projection system, and a pocket processor that processes the image for clarity and magnification. (Image courtesy Science Corporation.)
The 12-month data, presented at the 24th Euretina Congress in Barcelona, Spain, showed a meaningful improvement in visual acuity, with patients gaining an average of 23 ETDRS letters (4.6 lines) on a logMAR chart at 12 months post-implantation (Figure 2). One patient demonstrated a maximum improvement of 59 letters (11.8 lines). The most common serious adverse effect (SAE) reported was retinal break (8/38), followed by hypertony (elevated intraocular pressure) in the study eye (6/38) and subretinal hemorrhage (6/38).
Figure 2. Preliminary results from the PRIMAvera study, presented at the Euretina Congress, showed a showed a meaningful improvement in visual acuity. (Image courtesy Science Corporation.)
“While other therapies for GA aim at slowing progression, the PRIMA system may improve functional outcomes by restoring central vision,” the researchers concluded.
The study was designed to demonstrate PRIMA’s safety and efficacy to reach European market approval (CE mark). PRIMA is based on original research done at Stanford University and later by Pixium Vision, which was acquired by Science Corp.