Implantable visual prosthetics maker Second Sight Medical Products is set to conduct a clinical study of its Argus II Retinal Prosthesis System in better-sighted retinitis pigmentosa (tunnel vision) patients.
The firm has obtained approval from the German competent authority, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), and a positive opinion from the associated ethics committees.
Argus II Retinal Prosthesis System is being developed to deliver an electrical stimulation that would bypass defunct retinal cells and activate remaining viable cells, triggering visual perception.
The system coverts images that are captured by a miniature video camera placed on the patient’s glasses into a series of small electrical pulses.
The pulses are wirelessly transmitted to an array of electrodes implanted on the retinal surface.
Being conducted at three German centres, the clinical study will include implantation and assessment of the Argus II system in 10 subjects.
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Second Sight Medical Products president and chief executive officer Will McGuire has said that the system has the potential to improve the vision of additional blind patients with RP and will be rolled out by the end of the year.
McGuire added: “If successful, the targeted population could increase the potential market for the Argus II by two to three times its current size.”
The study’s primary endpoint is an improvement of the visual field, while the secondary endpoint is the ability of the patients to integrate the system into their daily lives.
The system is currently available at approved centres in the US, Canada, France, Italy, Germany, Russia, South Korea, Spain, Saudi Arabia, Turkey, the UK, and Taiwan.