Pixium Vision Announces 48-Month Trial Results in Severe Atrophic AMD
Pixium Vision SA announced data from a first in human trial to assess the efficacy and safety of the PRIMA photovoltaic retinal stimulation microchip for improving visual acuity (VA) 48 months post implantation in patients with severe central vision impairment due to dry age-related macular degeneration (AMD)
The trial data show that the implantation of PRIMA is feasible and well tolerated in all five study participants, with no reduction of natural peripheral visual function after 48 months. Using the prosthetic central vision provided by PRIMA, patients reliably recognized letters and sequences of letters with a clinically meaningful improvement in visual acuity of up to 8 lines, according to Pixium. The data currently undergoing journal peer review are available here.
In the beginning of Q2 2024, Pixium is expecting to report the full data readout from PRIMAvera, its European pivotal study, an open-label, baseline controlled, non-randomized, multicenter, prospective single-arm pivotal trial which has enrolled 38 patients (NCT04676854).
“One of the major visual disabilities for patients with age-related macular degeneration (AMD) and geographic atrophy is the gradual decline and then a permanent loss of reading ability within the central field,” Professor Frank Holz, Scientific Coordinator of the study, said in a company news release. “Unlike the current and potential pharmacological treatments for geographic atrophy, which aim to slow the growth of atrophic lesions without functional improvement in visual acuity, the PRIMA study results demonstrate restoration of central vision in the former scotoma. At the 4-year time-point, the mean gain was 32 letters, which corresponds to an improvement of logMAR 0.6 (6 lines) and should be considered clinically meaningful for patients with geographic atrophy with foveal involvement secondary to AMD.”
“We are delighted that thanks to our PRIMAvera pivotal study, 19 leading European retinal surgery sites have been trained in the minimally invasive procedure to implant our 2x2 mm photovoltaic sub-retinal microchip in under 2 hours,” said Ralf Hornig, PhD Director of Clinical Affairs.
“Further improvements of the AR glasses will widen the visual field, while the advanced image processing and stimulation protocol promise even more functional restoration of sight for patients suffering from atrophic macular degeneration no longer treatable with Pegcetacoplan injections,” said Daniel Palanker, of the Department of Ophthalmology and Hansen Experimental Physics Laboratory at Stanford University, who is leading the engineering development of Pixium’s next generation chip.
The PRIMA retinal prosthesis includes a microchip, which is self-sustaining and needs no wires for external power supply, inserted under the fovea. Each pixel of the implant (of which there are 378) independently converts light projected from transparent augmented-reality (AR) glasses into electric current stimulating the inner retinal cells, restoring vision in patients’ central blind spot. The retinal photovoltaic neurostimulation microchip is just 2-mm wide and 30-μm thick, carrying 378 electrodes of just 100 μm (1 μm = one millionth of a meter) in diameter.
Source: PLOS One
Pixium Vision is currently subject to receivership proceedings and is actively looking for buyers to acquire the company’s business. In that context, the company draws investors’ attention to the possibility that, in the event of a court-ordered plan to sell off all or part of the company’s assets, the price offered may not allow shareholders to be reimbursed in full or in part.
The deadline for submission of offers has been set to November 20, 2023, at 12:00 p.m. (noon) CET. Pixium said it will continue to regularly inform the market on the progress of the procedure and, more generally, of Pixium Vision’s financial situation.