FDA approves eye implant that helps restore vision in patients with retinal disorder
WASHINGTON — Patients who have lost their sight as a result of a rare disorder might be able to regain some vision using an implantable device that takes the place of damaged cells inside the eye.
The Food and Drug Administration approved the Argus II Retinal Prosthesis System as the first treatment for an inherited disorder that causes the breakdown of cells in the retina, a membrane inside the eye.
The technology will initially be available to a small number of patients, but could eventually be used to treat vision disorders that affect millions of people. The device was previously approved in Europe in 2011.
The system includes a small video camera and transmitter mounted on a pair of glasses. Images from the camera are processed into electronic data that is wirelessly transmitted to electrodes implanted into the patient's retina.
FDA says that while the device will not fully restore patients' vision, “it may allow them to detect light and dark in the environment,” which could help them perform daily tasks.
The FDA approved the device from Second Sight Medical Products for patients 25 and older who have advanced retinitis pigmentosa. Starting in their twenties, people with the disease slowly lose vision as the light-sensitive cells that line the retina deteriorate. Over a period of decades the condition eventually leads to blindness.
Dr. Robert Greenberg, CEO and founder of Second Sight, first proposed the technology for the Argus device as a doctoral student at Johns Hopkins University's medical school about 20 years ago. He founded Second Sight to develop the technology in 1998.
About 100,000 people in the United States have retinitis pigmentosa, though the FDA estimates fewer than 4,000 will initially receive the device under its currently approved indication. Patients must have little to no light perception in both eyes but a prior history of being able to make out basic shapes and forms. They also must have signs of at least some remaining retinal function.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- New Orleans slow to heal 10 years after Hurricane Katrina
- Thousands in New Orleans became targets of unscrupulous contractors
- Illinois Lottery winners get IOU instead of checks
- Surviving panda cub is male
- Kentucky county clerk’s protest of same-sex marriage near end
- George W. Bush visits disaster zone, 10 years after Katrina
- Prep school graduate Labrie convicted of sex charges
- Supreme Court has protest-free zone, judges panel rules
- ‘Facts are bad’ for pier-shooting defendant, legal experts say
- Clinton: Women ‘expect’ extremism from terrorists, not GOP candidates
- Court lifts injunction against NSA call records program