The Food and Drug Administration on Thursday approved the first treatment to give limited vision to people who are blind, involving a technology called the artificial retina. 
 
 The device allows people with a certain type of blindness to detect crosswalks on the street, the presence of people or cars, and sometimes even large numbers or letters. The approval of the system marks a milestone in a new frontier in vision research, a field in which scientists are making strides with gene therapy, optogenetics, stem cells and other strategies. 
 
 “This is just the beginning,” said Grace Shen, a director of the retinal diseases program at the National Eye Institute, which helped finance the artificial retina research and is supporting many other blindness therapy projects. “We have a lot of exciting things sitting in the wings.” 
 
 The artificial retina is a sheet of electrodes implanted in the eye. The patient is also given glasses with an attached camera and a portable video processor. This system, called Argus II, allows visual signals to bypass the damaged portion of the retina and be transmitted to the brain. 
 
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 With the artificial retina or retinal prosthesis, a blind person cannot see in the conventional sense, but can identify outlines and boundaries of objects, especially when there is contrast between light and dark — fireworks against a night sky or black socks mixed with white ones. 
 
 “Without the system, I wouldn’t be able to see anything at all, and if you were in front of me and you moved left and right, I’m not going to realize any of this,” said Elias Konstantopolous, 74, a retired electrician in Baltimore, one of about 50 Americans and Europeans who have been using the device in clinical trials. He said it helps him differentiate curbs from roads, and detect contours of objects and people. “When you have nothing, this is something. It’s a lot.” 
 
 The F.D.A. approved Argus II, made by Second Sight Medical Products, to treat people with severe retinitis pigmentosa, in which photoreceptor cells, which take in light, deteriorate. 
 
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 The eyeglass camera captures images, which the video processor translates into pixelized patterns of light and dark, and transmits them to the electrodes. The electrodes then send them to the brain. 
 
 “The questions that this particular device raised for F.D.A. were very new,” said Dr. Malvina Eydelman, the F.D.A.’s director for the Division of Ophthalmic and Ear, Nose, and Throat Devices. “It’s a big step forward for the whole ophthalmology field.” 
 
 About 100,000 Americans have retinitis pigmentosa, but initially between 10,000 and 15,000 will likely qualify for the Argus II, according to the company. To be eligible, people must be over 25, have previously had useful vision, and be so visually impaired that the device would be an improvement. 
 
 But experts said the technology holds promise for others who are blind, especially those with advanced age-related macular degeneration, the major cause of vision loss in older people, affecting about two million Americans. About 50,000 would be impaired enough for the device to help, said Dr. Robert Greenberg, Second Sight’s chief executive. 
 
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 In Europe, Argus II received approval in 2011 to treat severe blindness from any type of outer retinal degeneration, although so far it is marketed there for retinitis pigmentosa. In the United States, additional trials are necessary for such approval. 
 
 Eventually, the company plans to implant electrodes directly into the brain’s cortex to “allow us to address blindness from all causes,” Dr. Greenberg said. 
 
 Initially, Argus II will be available at seven hospitals in New York, California, Texas, Maryland and Pennsylvania. It will cost about $150,000, excluding surgery and training. Second Sight said it was optimistic that insurance would cover it. 
 
 Argus II was developed over 20 years by Dr. Mark S. Humayun, an ophthalmologist and biomedical engineer at the University of Southern California. Some financing came from private sources and the National Eye Institute, the National Science Foundation and the Department of Energy, all federal agencies. 
 
 Dr. Humayun said he envisioned applying the technology to other conditions than blindness, implanting electrodes in other parts of the body to address bladder control problems, perhaps, or spinal paralysis. “We don’t think of the human body as an electrical grid, but it runs off electrical impulses,” he said. 
 
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 The Argus II was approved under a special F.D.A. program designating it a “humanitarian use device,” which Dr. Eydelman said applied to therapies that would be used for fewer than 4,000 people a year. Argus II is only the 57th humanitarian device exemption granted by the agency. Companies applying for humanitarian device approval can conduct much smaller clinical trials — Second Sight submitted data on only 30 patients — and must only demonstrate safety and “probable benefit,” not proof of effectiveness, Dr. Eydelman said. 
 
 The F.D.A. worked with Second Sight to develop ways to measure that benefit, including tasks like walking on a sidewalk without stepping off, and matching black, gray and white socks. 
 
 Of the 30 Argus II clinical trial patients, 11 experienced a total of 23 negative effects, the F.D.A. said, including retinal detachment and erosion of the clear covering of the eyeball. 
 
 Dr. Eydelman said the company had “taken substantial steps” to address safety concerns, making “many device modifications.” Dr. Greenberg said only two people needed to have the implant removed. An F.D.A. advisory panel voted unanimously last September to recommend approval, finding that benefits outweighed the risks. 
 
 Some patients see more improvement than others, for reasons the company has not been able to determine. Kathy Blake of Fountain Valley, Calif., said she has had success with a Second Sight exercise to see if patients can identify large numbers or letters on a computer screen. 
 
 Dean Lloyd, a lawyer in Palo Alto, Calif., said he initially wondered, “Is it really worth all the time and expense? I, at first, did not think so.” Early on, only nine of the 60 electrodes were working, but over time his implant was adjusted so more electrodes responded, and now 52 of them work. He can see flashes of color, something not every patient can, and he wears the glasses and video processor constantly. 
 
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 “If I don’t wear it, it’s like I don’t have my pants on,” he said. “I’ve even fallen asleep with the blooming thing.” 
 
 Stephen Rose, the chief research officer for the Foundation Fighting Blindness, which supported Dr. Humayun’s very early work but has not financed it since, said the artificial retina would eventually be only one of the options to help blind people. 
 
 “I think there are tremendous possibilities,” he said. “I’m not downplaying the retinal prosthesis, don’t get me wrong. It’s huge for some individuals, and it’s here now.” 
 
 Barbara Campbell, 59, relishes how the device helps her navigate Manhattan streets, locate her bus stop, and spot her apartment building’s foyer light while riding in a taxi. 
 
 Most exciting, though, is how it enhances her experience of museums, theater and concerts. 
 
 At a performance by Rod Stewart, “I could definitely see his hair,” which was white-blond under the lights, she said. At a concert by Diana Ross, even though Ms. Campbell sat far away from the stage, she said Ms. Ross “was wearing a sparkly outfit, and I could see her.” 
 
 No such luck at a performance by James Taylor, though. His low-key clothing created no contrast for the artificial retina to register. Alas, Ms. Campbell said, “He wasn’t so sparkly.” ||||| Have scientists finally created a bionic eye? The quest to develop a device that will give some blind people vision again, a retinal prosthesis, has been challenging. Shirley Wang joins Lunch Break with the latest on the research. Photo: Second Sight. 
 
 Regulators have approved a bionic eye for the first time in the U.S., saying Second Sight Medical Products Inc.'s retinal prosthesis can be used to treat a certain kind of blindness. 
 
 The Food and Drug Administration approved the Argus II, which sends electrical stimulation to the retina to induce vision in individuals afflicted with retinitis pigmentosa. 
 
 This disorder, which can run in families, damages and kills the cells in the retina—a tissue layer at the back of the eye—that process light. The disease causes vision to become increasingly blurry until they can't see at all. Around 100,000 patients in the U.S. have the condition. 
 
 The Argus II, which is already available in Europe, can't restore sight completely, but it can improve vision in individuals who can see almost nothing. 
 
 Enlarge Image Close Associated Press The Argus II, which is already available in Europe, can't restore sight completely, but it can improve vision. 
 
 Earlier The Quest to Create a Bionic Eye Gets Clearer 1/28/13 1/28/13 
 
 "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," said Second Sight Chief Executive Robert Greenberg. 
 
 The device works by bypassing the damaged cells that process light. Video cameras mounted on glasses capture the visual information in the form of light; the data are then transmitted wirelessly to the implant to trigger electrodes in the chip to stimulate pixels of light on the retina. This information is then sent to the brain and processed normally as an image. 
 
 Enlarge Image Close Second Sight Medical Products/Reuters The 'Argus II implant' made by Second Sight Medical Products Inc. of Sylmar, California is shown in this handout artist's rendition 
 
 Argus II is set to become available later this year in U.S. clinical centers, and Second Sight said it would be adding sites to make the therapy more readily available. 
 
 To date, the technology allows the wearer to see in black and white, and is most useful for seeing sharp contrasts. But scientists hope that it will eventually enable color vision. 
 
 "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," said Mark Humayun, a doctor and medical professor at the University of Southern California who was involved with developing the device. 
 
 Scientists have said that designing a bionic eye has been much more difficult than developing aids like cochlear implants for hearing, in part because visual information is two-dimensional, and because of the anatomy of the eye. 
 
 There are also many technical challenges, such as how to add more electrodes into the tiny chip that sits on the retina—about 5 millimeters by 7 millimeters in the case of Argus II—to stimulate enough cells in the retina to produce a good quality image. Normal vision is based on more than one hundred million receptors in each eye that process light, say experts. 
 
 Many other academic centers and companies are working on competing technology they say is more advanced than Second Sight's. In 1991, when Second Sight's Dr. Greenberg was still in medical training at Johns Hopkins University, he watched a retinal surgeon perform a procedure where he placed a wire in a patient's eye and ran a bit of electrical current through it, and the patient saw a spot of light. The surgeon placed a second wire and the patient reported seeing two spots of light. 
 
 Dr. Greenberg could see the potential for creating a bionic eye if engineering issues could be worked out. "At that point, I thought it was an engineering project," he said in an interview earlier this year. "Little did I realize it would take 20 years before we would commercialize it." 
 
 The Sylmar, Calif.-based company was formed in 1998 by several co-founders, including entrepreneur Alfred Mann. With a number of academic collaborators, they fashioned an early retinal implant from a cochlear implant for the ear with 16 electrodes, each of which stimulated a small area of the retina. 
 
 Even with such a small number of electrodes that allowed for a small patch of vision, patients unexpectedly said they found the device useful by moving their heads back and forth and scanning the environment, said Dr. Greenberg. 
 
 The company chose not to commercialize the initial device because the surgery was complicated, taking four surgeons eight hours to complete it, said Dr. Greenberg. In the Argus II, the newer generation device, the surgery takes two hours and involves 60 electrodes. 
 
 Write to Shirley S. Wang at shirley.wang@wsj.com 
 
 A version of this article appeared February 15, 2013, on page B3 in the U.S. edition of The Wall Street Journal, with the headline: Bionic Eye Becomes a Reality. ||||| The 'Argus II implant' made by Second Sight Medical Products Inc of Sylmar, California is shown in this handout artist's rendition provided by Second Sight Medical Products Inc February 14, 2013. 
 
 Glasses and the Visual Processing Unit worn by the user in conjunction with the 'Argus II implant' made by Second Sight Medical Products Inc are shown in this handout photo provided by Second Sight Medical Products Inc February 14, 2013. 
 
 The 'Argus II implant' made by Second Sight Medical Products Inc of Sylmar, California is shown in this handout artist's rendition provided by Second Sight Medical Products Inc February 14, 2013. The U.S. Food and Drug Administration has approved the first 'artificial... 
 
 The U.S. Food and Drug Administration has approved the first artificial retina, an implanted device that replicates some of the function of the retina, helping to restore vision to people blinded with a rare genetic disorder, the agency said Thursday. 
 
 The device, made by privately held Second Sight Medical Products Inc of Sylmar, California, is intended to replace the function of light-sensing cells in the retina destroyed by retinitis pigmentosa, an inherited degenerative disease that affects about 100,000 people nationwide. 
 
 In a healthy eye, the retina, which lines the back of the inner eye, works a bit like film in a camera, converting images that come through the eye's lens into electronic signals that are relayed to the optic nerve in the brain. 
 
 To replicate this, the Argus II device consists of special glasses outfitted with a video camera and a video processing unit that sends signals to a wireless receiver implanted in the eye. 
 
 Although it does not completely restore vision, the implant helps with daily activities, such as locating objects and recognizing large letters and shapes. 
 
 "In the patients that have been implanted to date, the improvement in the quality of life has been invaluable," said Mark Humayun of the University of Southern California's Keck School of Medicine and USC's Viterbi School of Engineering, who helped develop the device. 
 
 The Argus II was approved for use in Europe in 2011 and has been implanted in 30 patients in a clinical trial that began in 2007. In October, advisers to the FDA voted unanimously to approve the device. 
 
 Brian Mech, vice president of business development at the company, said the system will cost more than $100,000 when it is launched in the United States, sometime this year. 
 
 Mech said the company is working with insurance companies and Medicare to win coverage and ease out of pocket expenses for patients. 
 
 The Argus II is intended to replace the function of light-sensing photoreceptor cells, which gradually become degraded in retinitis pigmentosa. 
 
 To restore vision, signals from the camera are sent to the retina, where they travel to the optic nerve in the brain. The brain then receives these signals and interprets them as a visual picture. 
 
 The FDA approved the system as a humanitarian use device, an approval that is limited to fewer than 4,000 people in the United States each year. For this kind of approval, companies must show the device is safe and the probable benefit outweighs the risks. 
 
 In the clinical trial, most of the 30 participants improved in their ability to see and touch a square on a white field, detect the direction of a motion, recognize large letters and sentences, see street curbs and even match socks. 
 
 To receive the Argus II device, patients must have had the ability to see forms in the past and must be willing and able to get the recommended follow-up care and training. 
 
 The device is limited to adults 25 or older, with severe to profound retinitis pigmentosa who have no light perception or bare light perception, in which they can perceive light but cannot tell where it is coming from. 
 
 The team plans to keep improving the treatment, which they hope will ultimately be used to treat age-related macular degeneration. 
 
 Mech said while there are many academic centers working on retinal implants, getting the system to market took 14 years, $200 million, and a lot of "intestinal fortitude." 
 
 (Reporting by Julie Steenhuysen in Chicago and Esha Dey in Bangalore; Editing by Sreejiraj Eluvangal and Cynthia Osterman)
– The FDA has approved the first use of an artificial retina or "bionic eye" to give the blind limited vision, reports the New York Times and Wall Street Journal. Users wear glasses outfitted with a video camera that transmits visual data to electrodes implanted in the eye; the signals bypass damaged parts of the retina and move along to the brain for processing. It is nowhere near full vision—users might be able to make out the contours of a person or the contrast of a curb from the road, for instance—but as one trial user puts it, “When you don’t have nothing, this is something. It’s a lot.” The device, called Argus II and made by Second Sight Medical Products in California, won the FDA's blessing to treat those with retinitis pigmentosa. It had already been approved in Europe, and it's hailed as just the start in similar technology. “We have a lot of exciting things sitting in the wings, multiple approaches being developed now," says a top official at the National Eye Institute. The Argus II should be available later this year in the US, but it's pricey—about $100,000, reports Reuters.