Wills Eye Hospital has been given FDA approval to begin an early feasibility study (EFS) to implant the RETINA IMPLANT Alpha AMS sub-retinal device in patients blind due to retinitis pigmentosa (RP).
The Alpha AMS is manufactured by Retina Implant AG, Reutlingen, Germany, and has been designed to replace the non-functioning and absent photoreceptor cells in the eye lost to the RP deterioration. The surgically implanted Alpha AMS chip stimulates the remaining components of the visual system to restore limited functional vision in blind RP patients. The eye’s own natural focusing system (without the need of a camera) focuses light on a chip made of 1600 photo diodes. The RETINA IMPLANT Alpha AMS is an investigational device in the US and has CE Mark approval in Europe since 2016.
“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,” Julia A. Haller, MD, Wills Eye Hospital Ophthalmologist-in-Chief, said in a company news release. “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 United States.”