FDA Approval For “Bionic Eye”

In short

Retinal prosthesis developer, Second Sight Medical Products, Inc. has announced that it’s Argus® II Retinal Prosthesis System has received U.S. FDA approval for use in the treatment of individuals with late stage retinitis pigmentosa (RP).

This announcement follows the product gaining European approval in 2011, and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012.

Background

RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 100,000 Americans. The Argus II System is intended to help the worst-affected RP patients, and this approval was made under a Humanitarian Device Exemption intended to expedite market introduction of technologies intended to treat smaller, underserved patient populations.

Argus II is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals with RP. Second Sight claim it has the capacity to offer life-changing visual capabilities to those currently unable to see anything except, at best, extremely bright lights.

The device works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function.

Argus II is the first and only approved retinal prosthesis anywhere in the world.

Company comments

“We are thrilled to be able to offer the only FDA-approved long-term therapy for people suffering from advanced RP,” said Robert Greenberg, MD, PhD, President and CEO of Second Sight. “With this approval, we look forward to building a strong surgical network in the United States and recruiting new hospitals that will offer the Argus II retinal implant. This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now.”

Physician comments

Although the resulting vision is not the same as when these patients had normal vision, investigators involved in the clinical trial of the Argus II are eager about the approval. “It is incredibly exciting to have FDA approval to begin implanting the Argus II and provide some restoration of vision to patients blinded from RP. In the patients that have been implanted to date, the improvement in the quality of life has been invaluable,” said Mark Humayun, MD, PhD, Cornelius Ping’s Professor of Biomedical Engineering, Professor of Ophthalmology, Biomedical Engineering, Cell and Neurobiology, Doheny Eye Institute at University of Southern California. “The fact that many patients can use the Argus implant in their activities of daily living such as recognizing large letters, locating the position of objects, and more, has been beyond our wildest dreams, yet the promise to the patients is real and we expect it only to improve over time.”

Source: Second Sight Medical, Inc. Image Copyright © 2013 Second Sight Medical Products, Inc.