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| An FDA panel voted to recommend the Argus II for approval--courtesy of Second Sight Medical Products |
In a significant boost for Second Sight Medical Products, an FDA panel of experts has overwhelmingly backed regulatory approval for the company's retinal prosthesis. The Argus II device is now well on its way to becoming the first of its kind approved for use in the U.S.
Winning the 19-0 vote from the FDA's Ophthalmic Devices Panel on Friday doesn't guarantee regulatory approval, as regulators aren't bound by the panel recommendation. But their decision frequently mirrors what the panel decides. Of note: The vote comes, as MedPage Today reports, after regulators and some committee members voiced concerns about safety and efficacy. To address this, the panel wants a pretty large post-approval study.
The Argus II is designed to restore a small part of vision to patients who are nearly blind from the inherited degenerative disease retinitis pigmentosa, using a retinal implant, glasses with an attached video camera and a wireless processing unit worn on a belt. The camera converts video images into small electrical pulses, which are transmitted wirelessly to the retina implant. This stimulates remaining cells and enables the brain to perceive light patterns. Over time, patients regain some sight as they learn to interpret the patterns.
Second Sight, which is based in Sylmar, CA, and Lausanne, Switzerland, says retinitis pigmentosa hits 100,000 people in the U.S. alone.
Second Sight is seeking regulatory approval, in part, based on a single-arm feasibility study of 30 patients. As the story explains, a majority of patients showed better visual acuity and half could read 8.9-inch letters from 12 inches away, but a sizeable minority required antibiotics or follow-up surgery to treat subsequent problems. Interestingly, the company submitted a version of the device for approval that contains some slight improvements over the one used in the study. That shouldn't be an issue, as some panelists said the changes should address any stated concerns, and the FDA said the tweaks won't add new safety problems, according to the article.
Argus II is already approved for use in Europe.
- read MedPage Today's coverage