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 wit.