Edison Issues Flash on Pixium Vision (PIX)

LONDON, UK / ACCESSWIRE / January 30, 2018 / Pixium Vision (PIX; FRA: PXH) announced on 25 January 2018 the first human activation of the Prima wireless photovoltaic sub-retinal implant, following successful implantation one month ago. These events occurred as per the protocol of the five-patient European Prima feasibility study, which was approved by regulators in October 2017 to assess the device in patients who have lost light perception in their central visual field due to atrophic damage from atrophic dry age-related macular degeneration. Following Prima activation, the patient reported light perception in the central visual field, where there had been none previously, and will now proceed to visual re-training to learn how to interpret the elicited light signals emitted by the Prima system. The successful Prima activation in this first patient is encouraging as an early suggestion of proof-of-concept that the device can interface with retinal cells to restore some visual perception. Additional implantations, along with results from the six-month safety assessment in this study, may further validate the Prima approach and potential.

The EU feasibility study is being conducted at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris. Interim data will be assessed at six months, with follow-up continuing until 36 months post-implantation. Six-month data, anticipated in H218, can, if positive, potentially lead to the commencement of an EU pivotal study in early 2019. This is in line with our current expectations.

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