FDA Advisory Panel Recommends“Bionic Eye” Prosthesis

A blind user carrying out tests for the Argus II retinal implant. Photo courtesy of Philippe Psaila/Science Photo Library.

“I think it’s a terrific system, it’s wonderful, it’s changed my life,” said Keith, a patient from Manchester, United Kingdom. His praise of the Argus II Retinal Prosthesis System by Second Sight Medical Products Inc. was part of recent testimony presented to a U.S. Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel charged with deciding whether the probable benefits of the Argus system outweighed health risks. The panel—one of the largest ever convened by the FDA—voted 19-0 that the benefits indeed outweighed any risks.

During the public comment period of the committee hearing, several patients were brought to tears as they described the first time they saw fireworks or the face of a loved one.

In making its determination, the panel—chaired by Eve J. Higginbotham, S.M., M.D.—spent 10 hours carefully reviewing and discussing data submitted from the international clinical trial of this retinal implant that, for the first time ever, partially restores vision to patients who are blind due to retinitis pigmentosa (RP). The clinical trial for the first generation Argus I retinal implant was held in 2002, and it was then that the device gained the “bionic eye” moniker. The panel, comprised of 19 voting members (23 members total) with expertise in ophthalmology, retinal disease, low vision, electrophysiology, and other specialties, heard testimony from the sponsor, the FDA, and several doctors and participants involved in the most recent clinical trial that began in 2007.

RP, an inherited retinal degenerative disease that often results in nearly complete blindness, affects roughly 200,000 Europeans and 100,000 Americans, and has been designated by the World Health Organization as an orphan disease—a rare condition that affects a very small portion of the population. In 2009, the Argus II received a Humanitarian Use Designation from the FDA, making it a candidate for humanitarian device exemption approval, which is designed to expedite the market introduction of technologies that treat smaller, underserved patient populations.

“I am very pleased with the panel recommendation,” said Robert Greenberg, M.D., Ph.D., president and CEO of Second Sight. “The panel deliberations were well informed and thorough and their decision validated over two decades of work by Second Sight and our collaborators. I would also like to thank all of the people around the world with RP who volunteered to participate in our clinical trials, and the doctors who treated them. Without their pioneering efforts, [this] result would not have been possible.”

“We are looking forward to working with the FDA now to quickly get the product approved,” said Anne-Marie Ripley, vice president of clinical and regulatory affairs at Second Sight. “There is no therapy available for these patients and we would like to make Argus II available to American doctors and their patients as soon as possible.”

The recommendation came after more than 20 years of work in the field, three clinical trials, more than $100 million in public investment by the National Eye Institute, the Department of Energy, and the National Science Foundation, and an additional $100 million in private investment. Many of the hundreds of people that have played instrumental roles in the development of Argus II were moved by the panel result.

“While the European approval last year was based on the safety and the long term performance of the Argus II Retinal Prosthesis System, the FDA panel required the demonstration of probable benefit as well,” said Lyndon da Cruz, M.D., Ph.D., consultant retinal surgeon at Moorfields Eye Hospital in London, United Kingdom, who presented the international trial data to the FDA panel in Gaithersburg, Md. “This recommendation will now give us the chance to improve the quality of life of thousands of blind patients who have absolutely no other treatment options. The landmark nature of the moment was reflected by one of the largest FDA panels ever convened and there were numerous patients who had benefited from the device giving moving testimonies of how the device had changed their lives.”

The Argus II received the CE Mark in 2011, making it the world’s first approved treatment for severe RP. Gregoire Cosendai, Ph.D., head of Second Sight’s Europe operations, said that Germany and Italy have shown “tremendous acceptance” to the system, showing commitment to providing it to patients at no cost. “We hope to see a similar level of support from England, France and other European countries,” he said.

“In Manchester, we enrolled three subjects in this trial, and obtained some tremendous results,” added Professor Paulo Stanga, vitreo retinal surgeon at Manchester Royal Eye Hospital and Director of the Manchester Vision Regeneration Lab, United Kingdom. “In further research, we have been able to demonstrate that patients blinded by RP could consistently perceive different colors at the same time using Argus II. This data is very encouraging because it suggests the possibility that Argus II with its software capability could be upgraded to one day restore color vision for these blind patients.”

Keith, the patient who gave his statement to the FDA panel, participated in a trial held in Manchester. He has been using the bionic eye since 2009.

“This is a truly exciting and historic moment for people with advanced inherited retinal degenerations such as RP,” said Stephen Rose, Ph.D., chief research officer at Foundation Fighting Blindness, which helped get the project started with early support.

The Argus II system 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 stimulate the retina’s remaining cells, resulting in the corresponding perception of patterns of light in the brain. Patients then learn to interpret these visual patterns, thereby regaining some visual function.

Presenters at the panel hearing described changes Second Sight would make to the market version of Argus II, including changing the radio frequency at which the glasses communicate to meet new international radio communication standards, modifying the implant chip to improve the wireless link between glasses and implant, and modifying the external component (the glasses) to improve ergonomics and ease of programming.

Second Sight Medical Products Inc., based in Los Angeles, Calif., was founded in 1998 to create a retinal prosthesis that would restore sight to patients blinded from outer retinal degenerations, including RP. Second Sight’s goal is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. The company’s European headquarters is in Lausanne, Switzerland.

The FDA is not bound by its panels’ recommendations, but it usually follows them.