Second Sight Medical Products has won FDA approval for its Argus II bionic eye for the treatment of late stage Retinitis Pigmentosa (RP). This announcement comes after the European approval in 2011, and widespread support from the FDA’s Ophthalmic Devices Advisory panel. The Argus II system was apparently shortlisted for approval under the Humanitarian Device Exemption, which has been put in place to expedite technologies for under-served patient populations.
With millions more suffering from other degenerative eye disease like glaucoma, macular degeneration, and diabetic retinopathy, it is likely that Second Sight will be facing some competition. Israel-based Bio-Retina has a similar device reported to provide nearly 600-pixel clarity in trials. Beyond that they are looking to develop a 5000-pixel device. With the Argus II, patients who could barely detect an extremely bright light, have reported the ability to recognize large letters and locate positions of household objects.
The bionic eye works by replacing the disease-damaged photoreceptors of the eye with tiny chips that translate light into electrical signals, which in turn stimulate the optic nerve. The normal retina is really not a camera, and the optic nerve does not send pixels, per say, to the brain, but rather a highly processed and optimally encoded representation of the visual scene. The fact that bionic eyes like the Argus II can work at all — and indeed so well — is due more to the brain’s ability to make sense out of whatever relevant signals it receives, than to current understanding of how the retina actually works. As researchers advance their understanding of the retina, bionic eye technology will continue to advance hand-in-hand to provide new vision to the blind at ever higher resolution.
Flashbacks: Argus II Retinal Prosthesis Gets European Clearance; Second Sight Medical Retinal Prosthesis Receives FDA Approval for Clinical Trials; Second Sight Implant: Positive Results Reported in the Study; Diamond Coating for Second Sight Implant; Argus II Retinal Prosthesis Implanted Into First Two Patients in Europe; Second Sight Medical Retinal Prosthesis to Receive a Wider Trial; Technology Behind Second Sight Retinal Prosthesis;
Product page: Argus II Retinal Prosthesis…