OcuDyne has announced the successful completion of a pilot study evaluating its Ophthalmic Percutaneous Transluminal Catheter (OPTiC) System for treating vascular lesions associated with geographic atrophy (GA). The study, conducted in Argentina, demonstrated the procedural feasibility of ophthalmic artery angioplasty and suggested potential benefits in visual function preservation.
Key Findings from the Pilot Study
The pilot study (OC-1901AR) met its primary endpoint by demonstrating the feasibility of the OPTiC System in performing ophthalmic artery angioplasty. Secondary and exploratory endpoints indicated subjective and objective evidence of visual function preservation at six months. Notably, no device-related adverse effects were reported, and all ocular adverse events with procedural causality were transient, resolving without treatment or sequelae.
Improvements in Visual Function
Subjective improvements in visual function were observed through Best-Corrected Visual Acuity (BCVA), MNRead acuity, critical print size, and reading speed assessments. Objective evidence of visual function preservation included growth inhibition of GA and a postoperative increase in sub-foveal choroidal thickness. These findings suggest that the OPTiC System may improve choroidal perfusion, potentially slowing the progression of GA.
OcuDyne's Perspective
Jeff Franco, CEO of OcuDyne, expressed enthusiasm about the trial results, stating that they support the company's hypothesis regarding the impact of retinal perfusion on macular function. He added that the company's next focus will be on developing additional data to support a pathway for regulatory approval. Franco is scheduled to present the final clinical data from the OC-1901AR study at the Ophthalmology Futures Retina Forum in Barcelona, Spain.
Future Directions
With the successful completion of this pilot study, OcuDyne is poised to further investigate the OPTiC System's potential in treating GA. The company's focus will be on gathering additional data to support regulatory approval, potentially paving the way for a new treatment option for patients with this debilitating condition.
