Ending the Journey through Darkness: Innovative Technology Offers New Hope for Treating Blindness due to Retinitis Pigmentosa
Second Sight announces FDA approval to begin clinical trial to test newest generation
of electronic retinal implant
SYLMAR, Calif., January 9, 2007 – A new implantable technology has the potential to bring light back to blind individuals with Retinitis Pigmentosa (RP). Second Sight® Medical Products, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to conduct a clinical study of the ArgusTM II Retinal Prosthesis System at centers of excellence across the United States.
The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to RP, a group of inherited eye diseases that affect the retina. RP causes the degeneration of photoreceptor cells in the retina, which capture and process light helping individuals to see. As these cells degenerate, patients experience progressive vision loss.
“This is a major milestone not only for the company but, more importantly, for RP patients who have little in the way of hope and treatment options,” said Robert Greenberg, M.D., Ph.D., president and CEO of Second Sight, and a leader in the field of retinal prostheses for over 15 years. “We have put together an outstanding group of clinical investigators and study sites around the country, and worldwide, to assess this device, and we are looking forward to getting started in the US.”
The Argus II implant consists of an array of electrodes that are attached to the retina and used in conjunction with an external camera and video processing system to provide a rudimentary form of sight to implanted subjects. An IDE trial of the first generation implant (Argus™ 16), which has 16 electrodes, is ongoing at the Doheny Eye Institute at the University of Southern California. The Argus 16 was implanted in six RP subjects between 2002 and 2004 and has enabled them to detect when lights are on or off, describe an object’s motion, count discrete items, as well as locate and differentiate basic objects in an environment. Five of these subjects are now using their Argus 16 retinal prostheses at home.
The next generation Argus II retinal stimulator is designed with 60 independently controllable electrodes, which should provide implanted subjects with higher resolution images. Second Sight remains the only manufacturer with an actively powered permanently implantable retinal prosthesis under clinical study in the United States, and the technology represents the highest electrode count for such a device anywhere in the world.
"This advanced artificial retina technology holds promise for providing even better detailed vision than the original device," says Stephen Rose, Ph.D., Chief Research Officer, Foundation Fighting Blindness. "The opportunity for restoring some functional vision is a very exciting prospect for people who are blind or have substantial vision loss."
The study will be conducted in subjects who:
The study will require each subject to be followed for at least three years with visits to the implanting center up to two times per week. Enrollment of subjects in the Argus II trial will begin at centers of excellence across the United States in early 2007.
Subjects with optic nerve disease, glaucoma, diabetic retinopathy, ocular trauma, or a history of retinal detachment are not suitable candidates for this study. Subjects must also be physically able to undergo general anesthesia. If you know of a suitable candidate, or if you are a physician with further questions, please contact patients@2-sight.com or 818-833-5027.
(Editor’s note: Supporting graphics and/or interviews with physicians familiar with Second Sight technology are available upon request.)
About Second Sight
Second Sight® Medical Products, Inc., located in Sylmar, Calif., is a privately held company founded in 1998 by Alfred Mann and others with the goal of creating 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 overcome their disability and achieve greater independence. The company has received extensive U.S. federal support in developing this new technology and is grateful for the forward thinking of the National Institutes of Health/National Eye Institute and the Office of Science at the Department of Energy in supporting significant aspects of this work.
This press release contains forward-looking statements. Second Sight Medical Products wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements, and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, regulatory approvals, reimbursement, and other factors. Second Sight is a registered trademark and Argus is a trademark of Second Sight Medical Products, Inc.