A German company that has developed an electrical chip allowing blind people to partially recover their vision hopes to commercialise its device as soon as the end of next year.
Walter Wrobel, chief executive of Retina Implant, based in Reutlingen, said he planned to seek authorisation for a CE mark during 2011 that would allow the chip to be approved across the EU as a medical device.
The launch – following 15 years of research – would offer fresh hope initially to an estimated 11,000 people across the industrialised world each year who develop retinitis pigmentosa, an inherited condition that leads to deterioration of the light sensitive cells in the retina.
It could also have potential applications for many more people who develop age-related macular degeneration, which also causes loss of vision, but not the still larger numbers with glaucoma, cataracts or diabetic retinopathy, which causes damage beyond the photo-receptors of the retina.
Dr Wrobel was speaking following publication in the Proceedings of the Royal Society journal this week of significant improvement in the vision of three patients who had the condition in a trial inserting the chip, after which they could locate bright objects on a dark table. One could recognise letters and approach people in a room.
A further eight patients who were earlier recruits in the same trial showed no such improvement, but had had the chip less intrusively inserted and not under the macular in the eye responsible for vision, where it was shown to have greatest effect.
The chip, which is inserted in an operation taking several hours, was powered by a cable run under the skin to the ear where it connects with an external battery. Because of the risk of infection, it was removed after the trial.
The company has already begun a second trial in up to 45 patients with the chip permanently implanted, and powered by an induction loop. Dr Wrobel estimated the price of the treatment would be €60,000-€80,000 ($85,000-$113,100).
Rival companies are also developing devices but are at an earlier stage. Another already in trials is by Second Sight in the US, but requires external glasses rather than an implant.
Robert MacLaren, professor of ophthalmology at the University of Oxford, who is to run clinical trial next year with the chip in conjunction with colleagues at King’s College, London, said: “In our field, this is pretty much as good as it gets. The technology is absolutely amazing. Medical innovation can take a long time to develop but when it does, it can make a real difference to real lives.”
David Head, chief executive at the charity Retinitis Pigmentosa Fighting Blindness, said: “This technology is very exciting. However these devices are at an early stage of development … and it’s important that we recognise that from early trials to a product that is fully proven and generally available can take a long time.”
The Financial Times