Retina Implant AG, the leading developer of subretinal implants for retinitis pigmentosa patients, today announced that its scientific advisory board is in full support of beginning the multi-center phase of the Company's second human clinical trial. The trial, which began in Tuebingen, Germany in 2010, will be expanded across Europe in five new sites, including two additional locations in Germany, Oxford, London and Budapest. Unlike the first human clinical trial, patients are able to keep the implant permanently and use the microchip in real-life settings.
“We are pleased that after reviewing the results of the first nine patients in the trial, the scientific advisory board is in agreement that the next stage of our research should begin”
"We are pleased that after reviewing the results of the first nine patients in the trial, the scientific advisory board is in agreement that the next stage of our research should begin," said Dr. Walter-G. Wrobel, CEO of Retina Implant AG. "The Board's continued support reinforces the progress Retina Implant continues to make on our journey to permanently restore useful vision to retinitis pigmentosa patients. Our team looks forward to continuing the momentum we've achieved in the trial thus far and to submitting for commercial approval when this next phase of research is completed."
The Board's endorsement is based on data from the first nine patients implanted during Retina Implant's second human clinical trial in which patients were implanted with Retina Implant's new wireless device, between May 19, 2010 and July 28, 2011. The results indicate the best visual acuity to-date, with the majority of patients experiencing restoration of useful vision in daily life. The vast majority of patients are experiencing visual perception indoors and outdoors in both dim and bright environments. Additionally, patients are reporting the ability to see objects 30 feet away and to read numbers on a pair of dice. Also factoring into the Board's decision to continue the trial is that the subretinal, surgical technique to implant the device continues to be safe and effective. Adverse events have been minimal and correctable, with patients going on to achieve positive functional outcomes.
Robert MacLaren, professor of Ophthalmology at Oxford University Hospitals NHS Trust will lead the trial at the Oxford site. He commented: "We are delighted to be involved in testing this pioneering subretinal implant technology. The results achieved by the Retina Implant team to-date represent a significant advance in this technology that could greatly enhance the quality of life for people with an incurable, blinding disease. We are looking forward to working with Retina Implant to build on this impressive body of evidence."
Retina Implant's subretinal implant technology has been in clinical trials for more than six years. Results from the Company's first human clinical trial published in Proceedings of the Royal Society B last November showed placement of the implant below the retina, in the macular region, provided optimum visual results allowing patients to recognize foreign objects and to read letters to form words. The results of this trial proved to be superior to any other approach in the retinal implant industry.
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