Pixium Vision has been awarded breakthrough device designation for the Prima System, an implant to help treat dry age-related macular degeneration.
The Paris-based company’s Prima System is a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision implanted in human patients with atrophic dry (AMD) to partially restore their vision.
"To receive this Breakthrough Device Designation and have FDA recognize the therapeutic potential of our Prima System is a significant achievement for Pixium Vision, especially as only a small proportion of devices awarded the designation are intended to treat ophthalmologic conditions," said Lloyd Diamond, CEO of Pixium Vision. "Our Prima System is making great progress in the clinic with a read-out on the primary endpoints due toward the end of this year. This designation not only helps us to expedite the development of the Prima System but also affords us the opportunity of working closely with the FDA in refining the Prima System for its US regulatory submission. 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."
The implant is being evaluated in the PRIMAvera study. The primary efficacy endpoint of the PRIMAvera study is the proportion of subjects with an improvement of visual acuity of logMAR 0.2 or more from baseline after 12 months, and the primary safety endpoint is the number and severity of device and procedure-related serious adverse events at 12 months follow-up. The study will include three years of follow-up, with an assessment of the primary endpoints at 12 months after implantation.
The company said there would be a read-out of its primary endpoints around the end of 2023, with a regulatory submission in Europe in H1 2024.
Two years ago, Pixium was in a very different space. The company had just terminated plans to acquire Second Sight Medical Products. The fall out between the two companies was because Second Sight filed for a private placement of $27.9 million, that Pixium said violated the memorandum of understanding between the two.
Sylmar, CA-based Second Sight would go on to merge with Nano Precision Medical to be rebranded as Vivani Medical.
Nearly a year after the merger plans were put on halt, a Paris Commercial Court ordered the merged company to pay Pixium $1.68 million for violating the MoU.