RARE Daily

FDA Approves Second Sight Medical Products’ Retinal Prosthesis System

March 10, 2021

Rare Daily Staff

The U.S. Food and Drug Administration approved Second Sight Medical Products’ Argus 2s Retinal Prosthesis System, a redesigned set of external hardware for the treatment of retinitis pigmentosa.

The glasses and video processing unit was initially approved for use in combination with previously implanted Argus II systems. The company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development.

The company said in addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing.

Second Sight’s Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound RP.

The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina’s remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, with the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval. Second Sight has discontinued new implants of the Argus II system.

“We are very pleased to have received this approval, as it presents an opportunity to offer external hardware that we believe enhance comfort and aesthetics compared with the legacy Argus II system,” said Matthew Pfeffer, acting CEO of Second Sight.

A decision on when or if to begin production of the newly approved hardware is pending completion of Second Sight’s planned business combination with Pixium Vision, which currently is in progress. Should the business combination be completed, the new management team will then evaluate how best to proceed with the Argus 2s Retinal Prosthesis System, as well as all other products in development.


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