Pixium Vision announces the 48-Month Trial Results in Severe Atrophic AMD
November 14 2023 - 1:00AM
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.
For more information:
http://www.pixium-vision.com/fr
Follow us on @PixiumVision;
www.facebook.com/pixiumvision
www.linkedin.com/company/pixium-vision
Contacts
Investor
RelationsPixium VisionOffer NonhoffChief
Financial Officerinvestors@pixium-vision.com |
Media
Relations Rose Piquante ConsultingSophie
BaumontSophie.baumont@rosepiquante-consulting.com+33 6 27 74 74
49 |
- 2023-11-13- Pixium - PR 48 months results - rev BB
12.11.23
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