13 January 2020 – San Francisco, California, USA
Bionic Vision Technologies Announces Interim Pilot Study Results of the BVT Bionic Eye System Designed to Help the Blind Achieve Greater Mobility and Independence.
Up to 44-Week Data Shows Significant Improvement in Both Obstacle Awareness and Object Detection
Bionic Vision Technologies today announced the interim results of a pilot study involving four patients with late-stage Retinitis Pigmentosa (RP) implanted with a visual prosthesis designed to improve awareness of external objects and patient surroundings. Results presented during the 38th Annual JP Morgan Conference in San Francisco demonstrated improved combined performance of all six functional vision tests at 44 weeks of active use of the device.
“These outcomes represent a significant milestone for Bionic Vision Technologies and give hope to many patients who have lost their sight due to late-stage RP,” said Ash Attia, CEO. “Based on these positive results, BVT intends to initiate a worldwide clinical trial for the commercialization of our Gen3 device which will offer improved performance and usability as well as a streamlined external design, similar to the appearance of traditional eyeglasses.”
This current two-year pilot study, being conducted at the Centre for Eye Research Australia (CERA) and the Bionics Institute in Melbourne, Australia, involves four adult participants with near total blindness caused by the inherited retinal disease, Retinitis Pigmentosa. Each study participant was unilaterally implanted with the BVT Gen2 suprachoroidal visual prosthesis in the eye with the least remaining vision. Mobility testing was initiated after a two-month surgical healing period followed by a 16-week period of vision rehabilitation training. Participants were asked to complete a series of six tests at 17 weeks following training and then at three monthly intervals from week 20 with the device turned both “on” and “off” to assess performance. Data has been collected up to 44 weeks for all patients and will continue to be collected for up to 104 weeks.
Of all mobility tests conducted, the most significant improvement in this cohort was observed with the Primary Obstacle Avoidance Task, which relies on participants identifying obstacles in their pathway. At 44 weeks, patients detected 74.3% of obstacles when the device was turned on, compared to only up to 4% of obstacles when the device was turned off. Considerable improvement was also recorded for the Location Task which relies on study participants identifying and touching an object similar to the shape of a window on a wall. At 44 weeks, subjects were able to locate and touch the window 70.3% of the time when the device was turned on, compared to only up to 24.4% of the time when the device was turned off.