This article is more than 5 years old. Information may no longer be current.

FDA approves Wills Eye Hospital for subretinal device study

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

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.”