Pixium Vision's subretinal PRIMA system meets interim study endpoints for dry AMD

Pixium Vision announced Tuesday that its wireless PRIMA chip met the endpoints of the PRIMA FS feasibility study at interim 6 months follow-up after implantation and rehabilitation for patients with advanced dry age-related macular degeneration (AMD).

CEO Khalid Ishaque remarked that "these results exceeded our initial expectations. For patients who had completely lost their central vision, PRIMA enabled the majority of them to begin to correctly identify patterns and letters." Further, Ishaque said the company expects these "first results to attract also eligible candidates for the PRIMA feasibility study recruiting in the US." He added "we look forward to the pivotal clinical phase in Europe and subsequent CE mark for PRIMA."

In the 36-month French feasibility study, which is designed to evaluate the wireless photovoltaic subretinal PRIMA chip in eliciting visual light perception, five participants with advanced dry AMD were provided with the implant in one eye.

According to Pixium Vision, interim results showed that PRIMA "can be safely implanted under the atrophic macula while preserving the residual natural peripheral visual acuity." Further, it said the microchip "[successfully elicited] light perception in the central retinal area in all subjects who had no remaining central visual activity." A majority of participants could also identify patterns, numbers or letters, while "the speed and accuracy of identifications improved continuously during the rehabilitation phase," the company reported. 

Pixium Vision added that the central prosthetic visual acuity measured up to 20/460 within the former scotoma with no remaining natural central vision, representing "the best [prosthetic visual acuity achieved] among those published from current visual prosthetic technologies." Moreover, the implant was well tolerated, with no device-related serious adverse events.

Pixium Vision stated that it is preparing the larger European multicentre pivotal study required for the CE mark. The company has also been cleared by the FDA to assess PRIMA in a similar five-patient study in the US.

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