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Wednesday, Jun 29, 2022

FDA Approves Trials for Second Sight’s New Prosthetic Eye

Second Sight Medical Products Inc. on Monday announced that it has received approval from the U.S. Food and Drug Administration to begin a human clinical study for its latest visual prosthesis system, Orion. The Sylmar manufacturers of medical products developed a similar product in the past called Argus II, which has been implanted in patients worldwide. Both Orion and Argus II outfits blind patients with glasses containing a small camera. While Argus’ camera sends electrical pulses to electrodes that are implanted on the patient’s retina, the Orion will send the information to an electrode implanted in the patient’s visual cortex, which is located on the most posterior portion of the brain. Duane Tsutsui, head of marketing at Second Sight, said that while Orion will deliver similar results to patients as Argus II, it will help more patients. “Argus II was for a very orphaned group of patients who are blind (those with Retinitis Pigmentosa),” said Tsutsui. “The reason we decided to go after a cortical implant was to expand the number of people who became blind from other causes.” If successful, Orion will be able to restore vision to patients blinded by glaucoma, diabetic retinopathy, cancer and trauma. The human clinical trial is conditional, meaning the FDA will regulate the nature of the protocol and types of patients receiving the implant, Tsutsui said. The clinical trials will be conducted at UCLA and Baylor College of Medicine in Houston. The company hopes to complete its first human implant of the Orion system in December. Shares of Second Sight (EYES) on Monday closed up 8 cents, or 8 percent, to $1.08 on the Nasdaq.

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