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 in Nature Communications, 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 were implanted subretinally with the wireless PRIMA implant and how their vision improved meaningfully 24 months after implantation. While all patients had a sight in the studied eye before implantation that would be defined as legally blind in many countries, 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 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. 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, intend to demonstrate the safety and the benefits of the Prima System in Pixium Vision's pivotal PRIMAvera study with read-out expected towards the end of 2023 and regulatory submission for market approval soon after. In the US, a feasibility study is also ongoing.