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OcuDyne completes successful pilot study of OPTiC System
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According to the company, the pilot study showed procedural feasibility of ophthalmic artery angioplasty in the treatment of vascular lesions associated with geographic atrophy (GA).
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OcuDyne has announced the successful completion of a pilot study using the company’s Ophthalmic Percutaneous Transluminal Catheter (OPTiC) System.
According to the company, the pilot study showed the procedural feasibility of ophthalmic artery angioplasty in the treatment of vascular lesions associated with geographic atrophy (GA). Secondary and exploratory endpoints associated with subjective and objective evidence of visual function preservation at 6 months were also demonstrated.1
No device-related adverse effects were reported, and all ocular adverse events with procedural causality were transient and resolved without treatment or sequelae.1
Furthermore, subjective evidence of visual function improvement was demonstrated in Best-Corrected Visual Acuity (BCVA), MNRead acuity, critical print size, and reading speed. Objective evidence of visual function preservation and increased choroidal perfusion were demonstrated in growth inhibition of GA and postoperative increase in sub-foveal choroidal thickness, according to the company.1
OcuDyne CEO, Jeff Franco stated, “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.
Franco will be presenting the final clinical data from the Argentina OC-1901AR study in Barcelona, Spain at the Ophthalmology Futures Retina Forum.2
References:
OcuDyne Announces Positive Results for the OPTiC System™ 6-Month Clinical Trial in the Treatment of Geographic Atrophy. Press Release; September 9, 2024. Accessed September 12, 2024. https://www.prnewswire.com/news-releases/ocudyne-announces-positive-results-for-the-optic-system-6-month-clinical-trial-in-the-treatment-of-geographic-atrophy-302242510.html
OPTiC System Final Data – Retina Forum 2024 in Barcelona. Accessed September 12, 2024. https://ocudyne.com/optic-system-final-data-retina-forum-2024-in-barcelona
