BROOKLYN
PARK, Minn., Sept. 9,
2024 /PRNewswire/ -- OcuDyne, Inc, a medical device
company employing a novel approach to the treatment of ocular
disease, announced today successful completion of a pilot study
using the proprietary OPTiC System in the treatment of Age-Related
Macular Degeneration (AMD).
- Procedural feasibility of ophthalmic artery angioplasty in the
treatment of vascular lesions associated with geographic atrophy
has been demonstrated, with a positive safety profile.
- Secondary and exploratory endpoints associated with subjective
and objective evidence of visual function preservation at 6 months,
has been demonstrated.
Interim data from this clinical trial were accepted and
presented at the annual Association for Research in Vision and
Ophthalmology (ARVO) meeting in Seattle,
WA in May 2024. Final data is
now available, is supporting a pivotal trial application in
Argentina, and will be presented
to the FDA as conversations with the Agency continue.
Safety
- All ocular adverse events with procedural causality were
transient and resolved without treatment or sequalae.
- All systemic adverse events with procedural causality were
expected potential events, treated, and resolved
without sequalae.
- There were no device related adverse events reported.
Effectiveness
Subjective evidence of visual function improvement was
demonstrated in Best-Corrected Visual Acuity, MNRead Acuity,
Critical Print Size, and Reading Speed, as well as Patient Reported
Outcomes associated with Mobility and Independence and Reading and
Accessing Information. Objective evidence of visual function
preservation and increased choroidal perfusion were demonstrated in
growth inhibition of geographic atrophy and postoperative increase
in sub-foveal choroidal thickness, respectively.
"The completion of this trial is the culmination of a decade of
focused scientific research into perfusion of the retina and how it
affects macular function. We are very excited with the trial
results and how these data support the OcuDyne hypothesis. Our next
focus will be the development of additional data to support a
pathway for regulatory approval," Jeff
Franco, CEO.
About Chronic Ischemic AMD and OcuDyne
The potential influence of a chronic ischemic environment
secondary to atherosclerotic vascular disease in the ophthalmic
artery, on the development of geographic atrophy in age-related
macular degeneration, is beginning to be more widely recognized and
understood. AMD is a complex disease that includes genetic,
lifestyle, and environmental influences. Ischemia has long been
understood to cause hypoxia and hypoxia is known to be present in
retinal atrophy. OcuDyne, Inc. is a clinical stage company
dedicated to exploring the potential causative implications of
cardiovascular disease on AMD and treating this disease with
cardiovascular therapies.
Investor Relations Contact
Jeff Franco, CEO
jfranco@ocudyne.com
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SOURCE Ocudyne, Inc.