EU Approves Science Corp.’s Sight-Restoring PRIMA Chip

Restoring Central Vision in Geographic Atrophy Patients

Geographic Atrophy (GA) is an advanced stage of Age-Related Macular Degeneration (AMD) and a leading cause of irreversible central vision loss in individuals over the age of 55 worldwide. This progressive condition leads to the destruction of photoreceptors in the macula, the central region of the retina responsible for sharp, detailed vision. Until now, there have been no effective treatments to restore lost vision for individuals suffering from this debilitating pathology.

The PRIMA subretinal implant, developed by the US-based neurotechnology company Science Corporation, offers a novel approach to addressing this significant medical need. The technology is based on converting visual information into electrical signals that stimulate the remaining inner retinal neurons, thereby allowing the brain to perceive visual patterns. The recent receipt of the CE Mark confirms the safety and efficacy of the PRIMA system, paving the way for its commercial use within the European Union.

PRIMA Subretinal Retinal Stimulation Technology

The PRIMA vision restoration system consists of three main components working together: a wireless implant, specialized glasses, and an external pocket-sized processor.

The Photovoltaic Implant Microchip

The core element of the system is the PRIMA implant itself, a miniature photovoltaic chip that is 30 microns thick and 2 millimeters wide. It contains 378 independent pixels, each equipped with its own photodiode, stimulation electrode, and ground. The chip is surgically implanted into the subretinal space, directly beneath the macula.

• The device is completely wireless and does not require an internal power source, as energy and data are transmitted via near-infrared light.
• Each pixel of the PRIMA chip functions as an independent electric current source, ensuring high precision and localization of retinal stimulation.
• The technology is designed to replace the function of lost photoreceptor cells by stimulating bipolar and ganglion cells of the retina, which remain functional in patients with geographic atrophy.

Specialized Glasses with Camera and Projector

The patient wears glasses equipped with a miniature video camera that captures the surroundings in real time. The captured image is processed by the external pocket-sized processor and then transmitted back to the glasses. Inside the glasses, a digital micromirror device (DMD) system projects the processed image using pulsating near-infrared light through the pupil of the eye directly onto the implanted retinal chip.

This near-infrared light activates the photodiodes within the pixels of the PRIMA chip. Each activated pixel generates a weak electric current proportional to the light intensity received, stimulating the adjacent retinal nerve cells. The resulting signals are transmitted along the optic nerve to the brain, where they are interpreted as visual perception.

Clinical Trials and PRIMA Application Results

The decision by EU regulators to approve PRIMA is based on the positive results from clinical trials conducted in France and the United States. The pivotal PRIMAvera trial, involving patients with advanced geographic atrophy, demonstrated stable and significant improvements in visual acuity for the majority of participants.

• Throughout the trials, patients were able to recognize letters, words, and simple shapes. In some cases, visual acuity improved by several lines on the logMAR chart, representing a clinically significant outcome.
• Patient monitoring over several years confirmed the long-term safety and stable functioning of the implant within the human body.
• The technology proved effective even in cases where the patients’ residual natural vision was extremely low, providing artificial visual perception in the central zone where it had been completely lost.

Comparing the PRIMA System to Other Treatments

Currently, existing treatments for geographic atrophy, such as complement inhibitor injections, focus on slowing the progression of the disease but cannot restore lost vision. PRIMA is the first and only technology to actually restore functional central vision.

Commercial Launch in Europe and Future Outlook

Receiving the CE Mark allows Science Corporation to begin the commercial implementation of the PRIMA system in countries within the European Union. The first commercial launch is planned in Germany, where the company is already collaborating with leading ophthalmology centers to train surgeons and prepare clinical infrastructure.

Science Corporation is also continuing to work on enhancing the technology and expanding indications for its use. The company is in talks with US regulatory bodies (FDA) about the possibility of conducting clinical trials and obtaining approval to enter the American market. It is expected that in the coming years, the technology will become more accessible to patients worldwide, offering hope for vision restoration to individuals facing this severe pathology.

The introduction of such innovative neurotechnologies opens up new horizons in medicine, demonstrating the feasibility of restoring lost bodily functions through advanced microelectronic implants. Continued research and clinical experience with PRIMA will allow for a better understanding of the technology’s potential and limitations, as well as the development of new methodologies to improve patient quality of life.