Pixium Vision, a company looking to help circumvent blindness with the use of a bionic implant, may have just been granted a shortcut at the FDA.
The French developer received a breakthrough designation for its Prima system, which aims to replace failing light receptors in the back of the eye among people with a type of age-related macular degeneration known as dry AMD.
The Prima system aims to partially restore the ability to see at the center of a person’s visual field, the area most affected by the condition, while their peripheral vision continues to work naturally. It includes a wireless retinal implant, about two millimeters square, plus a camera mounted on a pair of glasses connected to a pocket-sized processing unit.
Images from the camera are sent to the implant chip as near-infrared light, which then converts the information into electronic signals for the retina’s nerve cells.
The company announced last December it had finished implanting the devices in 38 patients with dry AMD as part of a pivotal, single-arm clinical trial aimed at securing a European approval in the first half of 2024. Pixium said the study is on track and it expects to deliver early findings at the end of this year; it has also been conducting feasibility studies in the U.S. and France.
The new breakthrough designation, meanwhile, grants Pixium the chance to work closer with FDA officials during its upcoming premarket review process.
“In addition, after receiving market authorization, there are outpatient and inpatient reimbursement pathways that are more readily accessible as a result of receiving Breakthrough Device Designation,” Pixium CEO Lloyd Diamond said in a release.
Earlier this year, Pixium demonstrated how the second generation of its Prima implant could increase vision resolution by five times compared to the current version—enough to possibly help a person recognize faces or read smaller fonts.
Under development through a collaboration with Stanford University, researchers demonstrated that a new design of the implant’s photovoltaic array could allow for smaller pixels and clearer signals from each, potentially achieving 20/100 vision when reading letters without magnification.
Their preclinical study was published last November in Nature Communications (PDF). The company said the next-generation implants are currently being developed for future clinical trials.