LOS ANGELES and LAUSANNE, Switzerland--(BUSINESS WIRE)--Second Sight Medical Products, Inc., the world’s leading developer of retinal prostheses for the blind, announced positive interim results from a single-arm, controlled, prospective, multicenter clinical trial of its Argus II Retinal Prosthesis. The six-month results will be published in the April edition of the leading peer-reviewed journal Ophthalmology, the journal of the American Academy of Ophthalmology. Argus II gained European market approval in February 2011, the only retinal prosthesis in the world to achieve this status. The European market approval of this class of medical devices requires a demonstration of safety and performance with long-term clinical testing, and compliance to strict quality standards.
“The Argus II retinal prosthesis is now approved as a medical implant in Europe and the results to date are very encouraging for patients with end-stage outer retinal degenerations such as retinitis pigmentosa (RP),” said Mark Humayun, MD, PhD, Professor of Ophthalmology, Biomedical Engineering at Doheny Eye Institute, at University of Southern California, lead author of the study published this month by Ophthalmology. “The results from the trial demonstrated long-term reliability and showed that the previously blind subjects performed better at visual tasks with the Argus II system such as object localization and motion discrimination. The best visual acuity achieved by a subject in this study was 1.8 logMAR (Snellen equivalent, 20/1262), a substantial visual improvement over blindness.”
A total of 30 patients were implanted with the prosthesis and followed up for a minimum of six months and up to 2.7 years at the time the article was authored. Three types of visual acuity tests were performed using computer monitors: square localization, direction of motion and grating visual acuity. Two types of real-world orientation and mobility (O&M) tests were performed: a door test where subjects were asked to find a door across a room and a line test where subjects were asked to follow a white line on the floor.
Subjects performed statistically better with the Argus II system on versus off in the visual tasks:
- 96% of subjects improved in object localization
- 57% of subjects improved in motion discrimination
- 23% of subjects improved in the discrimination of oriented gratings
In addition, significant improvements in the O&M tasks were noted and the safety profile of Argus II was found to be comparable to other ophthalmic devices and procedures. Although there are several research efforts in retinal prostheses worldwide, none has demonstrated the reliability and efficacy of such a device in a multicentered, long-term, controlled clinical trial involving 30 subjects, as was demonstrated by the Argus II in this study.
“The Argus II can, quite simply, help the blind see,” said Dr. Stanislao Rizzo, Director of the U.O. Chirurgia Oftalmica, Azienda Ospedaliero Universitaria Pisana of Pisa, and the first surgeon to implant Argus II following European market approval. “Having an approved device backed by significant clinical data is cause for great hope among those patients suffering from RP. There is finally a real solution that means that their vision can be partially restored, safely.”
About Argus II
Argus II is Second Sight’s second-generation implantable device intended to treat blind people suffering from degenerative diseases such as retinitis pigmentosa and the first market-approved retinal prosthesis in the world. The system works by converting video images captured from 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 (epiretinal). These pulses are intended to 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 gaining some functional vision. The clinical study showed that patients achieved significant gains in visual function, including object detection, improvements in orientation and mobility, letter recognition, and even reading words and sentences in the best cases.
About Second Sight
Second Sight Medical Products, Inc., located in Los Angeles, California, was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations, such as retinitis pigmentosa. Through dedication and innovation, Second Sight's mission is to develop, manufacture and market implantable visual prosthetics to enable blind individuals to achieve greater independence. Argus II is not yet approved for sale in the United States. European headquarters are in Lausanne, Switzerland. For more information, go to www.2-sight.com.