Approval to distribute the Alpha IMS wireless implant for retinitis pigmentosa (RP) has been granted in Europe to Retina Implant AG, based in Reutlingen, Germany. Thirty-six patients have received the subretinal implant, designed to restore useful vision to people legally blinded by RP.
Retinitis pigmentosa is a generative eye disease that begins in young people and may be inherited. RP patients may be able to regain enough sight from this implant to perform daily activities and remain independent. “We are delighted that the Alpha IMS subretinal implant has received CE marking (the mandatory conformity marking for products sold in the European Economic Area), validating the safety and potential benefits of our revolutionary product to patients and physicians,” stated Walter-G Wrobel, Ph.D. and CEO of Retina Implant AG.
The Alpha IMS is implanted behind the retina on the macular region. Consisting of 1,500 electrodes, the implant surpasses any other device currently being used in humans. Results from Retina Implant AG’s second clinical trial were published in Proceedings of the Royal Society of B. These trials showed that patients with the chip regained ability to recognize faces and read identification signs on doors.
The first trial, in 2010, indicated similar results including the reading of type and the dots on dice. “After more than seven years of rigorous testing in 36 patients, we are pleased to have demonstrated the safety, reliability and tolerability of the Alpha IMS. It was a very rewarding and touching experience to see blind patients regain some vision that helped them to better master the activities of daily life,” said Professor Eberthart Zrenner of the Institute for Ophthalmic Research at the Centre for Ophthalmology of the University of Tuebingen. He added that the Alpha IMS provides a landmark in the journey to expand the limited number of available RP treatments.