Pixium Vision SA announces data from a first in human trial to assess the efficacy and safety of the PRIMA photovoltaic retinal stimulation microchip for improving visual acuity 48 months post implantation in patients with severe central vision impairment due to dry age-related macular degeneration
Pixium Vision announces the 48-Month Trial Results in Severe Atrophic AMD
- Study confirms subretinal prothesis feasible and well-tolerated with no reduction of natural peripheral vision, confirming 36-month results
- Patients suffering from central vision loss reliably recognized letters and sequences of letters, a clinically significant improvement
- Full data readout of accompanying pivotal PRIMAvera trial expected early 2024
- Pixium Vision reiterates that it is subject to receivership proceedings and is actively seeking buyers for its assets
Paris, France, 14, 2023 – 7:00 am (CET) – Pixium Vision SA (Euronext Growth Paris - FR001400JX97; Mnemo: ALPIX), a bioelectronics company developing innovative vision systems to enable patients who have lost their sight to live more independent lives, today announces 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 (dry 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 eight lines. 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, multi-center, 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,” commented Professor Frank Holz, Scientific Coordinator of the study, “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 (six 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” stressed 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” predicted Daniel Palanker, the Department of Ophthalmology and Hansen Experimental Physics Laboratory at Stanford University CA USA, 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 (central part of the retina). 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.
As a reminder, the Company 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 will continue to regularly inform the market on the progress of the procedure and, more generally, of Pixium Vision’s financial situation.
About Pixium Vision
Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The Company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
Forward-Looking Statements. This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risques”) section of the Company’s 2022 Annual Financial Report and other documents the Company files with the AMF, which is available on the AMF website (www.amf- france.org) or on the Company’s website.
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