Pixium Vision Announces the Publication of Peer-Reviewed Clinical Data Demonstrating the Clinical Benefit of the Prima System in Dry AMD Patients

Pixium Vision SA announced the publication of a paper in Nature Communications outlining further data with its Prima System, a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision in atrophic dry age-related macular degeneration (AMD).

The peer-reviewed paper, entitled “Simultaneous Perception of Prosthetic and Natural Vision in AMD Patients,” outlines how five patients with geographic atrophy enrolled in the French feasibility study successfully. They were implanted subretinally with the wireless PRIMA implant and their vision improved meaningfully 24 months after implantation. All patients had sight in the studied eye before implantation, but would be defined as legally blind in many countries, according to a Pixium Vision news release. All demonstrated a sighted eyesight while using the electronic magnification up to a factor of 8. In practice this means progressing from being able to only perceive shapes, to being able to read text on a page.

These are the first peer-reviewed clinical data for the Prima System showing simultaneous use of the central prosthetic and peripheral natural vision in dry AMD. The data showed Landolt acuity of 1.17±0.13 pixels, which demonstrates that the resolution of the perception is close to the resolution of the chip. Thanks to the “zoom” function that the Prima System is equipped with (electronic magnification up to a factor of 8), patients were able to improve their prosthetic visual acuity from 20/182 to 20/428 without the system, a level defined as legal blindness in many countries, to a range of 20/63-20/98. This represents a meaningful improvement of 5 to 6 lines on a letter chart over their vision without the Prima system, according to Pixium. 

“The peer-reviewed publication of these data in the prestigious journal of Nature Communications demonstrates the validation by our peers of the highly innovative and promising nature of our Prima System for the treatment of dry AMD,” Lloyd Diamond, CEO of Pixium Vision, said in the news release. "The data highlighted in this publication not only support that patients can combine their remaining peripheral vision with our bionic vision, that the resolution of perception is close to the resolution of the implant, and also very importantly exhibit that the natural peripheral vision is not reduced over time following the implantation. The pivotal PRIMAvera study is ongoing in Europe and we look forward to demonstrating these great benefits in a larger pool of patients, targeting to bring the Prima System to the European market in 2024.”

The key take-aways from the data published in Nature Communications are:

• The Prima System implant was generally well tolerated over the 18-24 months period  
• The synchronous perception of natural and prosthetic vision has been demonstrated
• Environmental background light was well tolerated
• A visual acuity of up to 20/63, significantly better than the legal blindness of 20/200 in many countries, was achieved
• Resolution of perception is close to the resolution of the implant (1.2 pixels)
• The benefits of the Prima System were maintained over 24 months
• The natural vision was not reduced over time following the implantation of the implant

In Europe, Pixium Vision intends to demonstrate the safety and the benefits of the Prima System in the company's pivotal PRIMAvera study with read-out expected toward the end of 2023 and regulatory submission for market approval soon after. In the US, a feasibility study is also ongoing.

The full peer-reviewed Nature Communications paper is available online here.