Newswise — BROOKLYN PARK, Minn., Sept. 9, 2024 /PRNewswire/ — OcuDyne, Inc., a medical device company utilizing a novel approach to treat ocular disease, announced today the successful completion of a pilot study using its proprietary OPTiC System for treating Age-Related Macular Degeneration (AMD).
The study demonstrated the procedural feasibility of ophthalmic artery angioplasty in treating vascular lesions associated with geographic atrophy, showing a positive safety profile. Secondary and exploratory endpoints showed evidence of visual function preservation over six months.
Interim data from the trial was presented at the ARVO meeting in Seattle in May 2024. Final data supports a pivotal trial application in Argentina and ongoing discussions with the FDA.
Safety
- All ocular adverse events linked to the procedure were temporary and resolved without treatment.
- Systemic adverse events, while expected, were treated and resolved without long-term effects.
- No device-related adverse events were reported.
Effectiveness Subjective improvement in visual function was observed in various metrics such as Best-Corrected Visual Acuity, Reading Speed, and Patient Reported Outcomes related to Mobility and Independence. Objective evidence showed growth inhibition of geographic atrophy and increased choroidal perfusion post-surgery.
“The completion of this trial reflects a decade of scientific research into retina perfusion and its impact on macular function. We’re excited about the trial results and their support of the OcuDyne hypothesis,” said Jeff Franco, CEO. The company’s next goal is to gather further data for regulatory approval.
About Chronic Ischemic AMD and OcuDyne A chronic ischemic environment, caused by atherosclerotic vascular disease in the ophthalmic artery, is increasingly recognized as a factor in geographic atrophy in AMD. AMD is influenced by genetics, lifestyle, and environmental factors, with ischemia known to cause hypoxia, which is present in retinal atrophy. OcuDyne is dedicated to addressing the cardiovascular causes of AMD through innovative therapies.
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