German ophthalmic device company, Retina Implant AG, has seen results from its clinical trial that led to CE mark of the Alpha IMS subretinal implant, presented at the American Academy of Ophthalmology (AAO) annual meeting.
Background
Retina Implant AG, develops subretinal implants for patients blinded by retinitis pigmentosa (RP). RP is one of the most common forms of inherited retinal degenerations affecting 1.5 million worldwide. A progressive condition that gets worse over time, RP typically causes severe vision problems in adulthood. Retinal implants represent promise for enabling RP patients to regain functional sight.
The Alpha IMS is a tiny 3×3 mm wireless subretinal microchip with 1,500 electrodes implanted below the retina, specifically in the macular region. The Alpha IMS provides artificial vision in implanted patients partly by taking over, in part, the function of the photoreceptors within the eye and transmitting the visual image in the form of electrical signals to the bipolar cells.
Dr. Katarina Stingl, clinical scientist from the Centre for Ophthalmology, University of Tuebingen, Germany presented during the course entitled; “2013 Modern Technologies and Techniques for Young Ophthalmologists to Know,” which covered new techniques, approaches and therapies for treating hereditary retinal degenerations that are in use internationally, but are not yet available in the United States.
The key focus of Dr Stingl’s presentation was clinical trial results of the Alpha IMS subretinal implant, which obtained CE mark to restore useful vision to RP patients in July 2013. The results, also published earlier this year in Proceedings of the Royal Society Biological Science, found that functional vision was restored in the majority of patients implanted with a wireless subretinal microchip. Patients were followed over an observation period of three to nine months and reported benefits such as regaining the ability to read letters and see facial characteristics.
Physician comments
“Being invited to present research to this great group of individuals at this prestigious meeting was quite an honor,” said Dr. Katarina Stingl. “After years of research we are finally able to provide a path to restore parts of functional vision for people suffering from end-stage retinitis pigmentosa, a degenerative disease that most often leads to blindness. It’s been thrilling to be part of this ground breaking research, and it’s a privilege to share our learnings with my esteemed peers.”
Company comments
“A lot of progress has been made in the decade since Retina Implant was born. Our success is due, in large part, to outstanding researchers, like Dr. Stingl, who have led our clinical trials,” said Walter-G Wrobel, CEO of Retina Implant AG. “Our immediate focus is to expand access to our technology within the European Union as well in other parts of the world, including working with the FDA to approve a trial in the U.S.”
Source: Retina Implant AG., PR Newswire
published: November 19, 2013 in: Clinical Studies/Trials, Congresses and Meetings, Ophthalmics