FDA Approves Subretinal Device Study
The FDA has approved an early feasibility study of Retina Implant’s Alpha AMS subretinal device in blind patients with retinitis pigmentosa, Wills Eye Hospital announced in a press release.
Wills Eye Hospital, the sole sponsor of the study in North America, will enroll up to eight subjects for implantation of the investigational device, the release said. The Alpha AMS device, which is CE marked in Europe, is designed to replace the eye’s nonfunctioning and absent photoreceptors and to restore some functional vision by stimulating the remaining parts of the visual system. The eye rather than a camera focuses light on a chip made of 1,600 photo diodes.
“This study represents the very earliest phase of clinically testing a potential new option for patients and families grappling with the devastating blindness caused by retinitis pigmentosa,” Wills Eye Ophthalmologist-in-Chief Julia A. Haller, MD, said. “We are thankful for the smooth process in working with the FDA and for the opportunity of offering this exciting technology in the form of an EFS investigational study to our blind RP patients for the first time in the U.S.”