Second Sight Medical (NSDQ:EYES) said today it won approval from Germany’s BfArM regulatory body to initiate a 10-patient study exploring the use of its Argus II retinal prosthesis system in better sighted retinitis pigmentosa patients and individuals with tunnel vision.
The Argus II induces visual perception in patients with retinitis pigmentosa by stimulating of the retina’s remaining cells with electrical pulses, which allows for the perception of light patterns to the brain, the Sylmar, Calif.-based company said.
“This is an important study and part of our strategy to evaluate the Argus II in better sighted individuals. We are excited by the opportunity to potentially improve the functional vision of additional blind individuals suffering from RP and look forward to initiating enrollment by the end of this year. If successful, the targeted population could increase the potential market for the Argus II by two to three times its current size,” prez & CEO Will McGuire said in a press release.
The clinical trial will take place at 3 sites across Germany, the company said, with a primary endpoint evaluating improvement of the visual field added by the Argus II for RP patients with tunnel vision.
A secondary endpoint will evaluate how well patients treated with the Argus II integrate the system into daily life, Second Sight said.
“This study has the potential to change the management of patients with RP and, if successful, greatly expand the patient population who can benefit from this treatment, and for whom the Argus II could be a solution,” Dr. Walter of Germany’s Universitätsklinikum Aachen said in a prepared statement.
In July, Second Sight said its Argus II retinal prosthesis system won expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 additional states and the District of Columbia.
See the best minds in medtech live at DeviceTalks West, Dec. 11–12 in Orange County, Calif.