Amydis Inc., is a company devoted to the
development of ocular biomarkers for the detection of diseases of the eye,
heart and brain. In the end of last year, the company announced the launch of
its Phase 2 clinical program for the study of a novel retinal tracer,
AMDX-2011P, which can detect amyloid-beta in glaucoma patients. This biomarker
can detect molecular changes in the retina, which can add to the
structural-functional changes seen in glaucoma patients.
There are reports suggesting amyloid-beta
is a key factor in the pathogenesis of glaucoma. Amyloid beta is also
associated with the development of Alzheimer’s disease, suggesting glaucoma is
an “ocular Alzheimer’s disease”.
The patented retinal tracer, AMDX-2011P, is
a small molecule which can be used to detect and quantify amyloid beta deposits
in the retina using currently available imaging devices. Therefore, the
procedure claims to increase the capture rate of glaucoma and improving
clinical management. This is achieved through earlier intervention and
potentially, facilitate amyloid beta targeted neuroprotective therapies.
In collaboration with the University of
California-San Diego (UCSD), Amydis completed proof-of-concept studies
demonstrating the Amydis tracers detect amyloid beta in post-mortem human eyes
of glaucoma patients, but not healthy subjects. The results have been submitted
for publication.
Dr. Stella Sarraf, Amydis founder and chief
executive officer was quoted, “We are thrilled to launch a new clinical program
for an eye disease. Enabling micron-level in-vivo tracking of retinal amyloid
beta formation in glaucoma patients will add a gain-of-function test to current
loss-of-function testing, empowering doctors to deliver better patient care,” “Our
goal is to also facilitate the development of neuroprotective agents to help
provide more therapeutics for patients.”
“If successful, the creation of a molecular
endpoint with the Amydis technology has the potential to enhance standard of
care for glaucoma patients by enabling improved diagnostic and prognostic
evaluation, as well as being used as an endpoint to develop neuroprotective
therapies,” said Dr. Robert N. Weinreb, Chair of the Amydis Scientific Advisory
Board, Chair and Distinguished Professor of Ophthalmology at UCSD and Director
of Shiley Eye Institute.
Amydis has launched a phase 2 open label,
blinded endpoint assessment study of AMDX-2011P as a retinal tracer in subjects
with primary open angle glaucoma. This trial is being conducted at three sites
in Southern California to collect multi-modal retinal imaging data on 40
subjects. This multi-modal data will include optical coherence tomography (OCT)
and OCT Angiography (OCT-A), enabling Amydis to map retinal amyloid beta,
retinal structure (OCT), and retinal vascular (OCT-A) signatures and monitor
their relative changes to better understand the pathophysiology of glaucoma.
Much like DARC technology, this technique
also relies on intravenous injection of the tracer. That is an impractical
technique for most patients visiting OPD clinics. Such diagnostic methods need
to develop drops or use other routes for the tracer to reach the retina.
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