Wills Eye Hospital has been given Food and Drug Administration (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).
PHILADELPHIA, Aug. 1, 2018 /PRNewswire/ -- Wills Eye Hospital has been given Food and Drug Administration (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. 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.,” noted Julia A. Haller, MD, Wills Eye Hospital Ophthalmologist-in-Chief.
Retinitis Pigmentosa is a degenerative eye disease which is the leading cause of inherited blindness in the developed world. There is no known cure for RP which affects an estimated 100,000 people in the USA and 1.5 million people worldwide. Approximately 1,500 individuals with RP each year progress to total blindness. Wills Eye Hospital is the only site in North America conducting this investigational research study and will enroll up to eight patients for implantation. If this initial study demonstrates encouraging results, a larger pivotal study will be performed to gain FDA approval.
About Wills Eye Hospital:
Wills Eye Hospital is a global leader in ophthalmology, established in 1832 as the nation’s first hospital specializing in eye care. U.S. News & World Report consistently ranks Wills Eye as one of America’s top ophthalmology centers since the survey began in 1990. Wills Eye is a premier training site for all levels of medical education. Its resident and post-graduate training programs are among the most competitive in the country. Wills provides the full range of primary and subspecialty eye care for improving and preserving sight, including cataract, cornea, emergency care, glaucoma, neuro-ophthalmology, ocular oncology, oculoplastics, pathology, pediatric ophthalmology and ocular genetics, refractive surgery and retina. To learn more, please visit www.willseye.org.
Media Contact:
Cathy Moss
cmoss@willseye.org
M-917-301-6773
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SOURCE Wills Eye Hospital
