OcuDyne Inc. announced the successful completion of a pilot study using the proprietary OPTiC System in the treatment of AMD. The results of the study revealed that procedural feasibility of ophthalmic artery angioplasty in the treatment of vascular lesions associated with geographic atrophy (GA) has been demonstrated, with a positive safety profile. In addition, secondary and exploratory endpoints associated with subjective and objective evidence of visual function preservation at 6 months, has been demonstrated, the company said in a press release.

According to OcuDyne, all ocular adverse events with procedural causality were transient and resolved without treatment or sequalae. In addition, all systemic adverse events with procedural causality were expected potential events, treated, and resolved without sequalae. There were no device-related adverse events reported.

In addition, subjective evidence of visual function improvement was demonstrated in BCVA, MNRead Acuity, Critical Print Size, and Reading Speed, as well as Patient Reported Outcomes associated with Mobility and Independence and Reading and Accessing Information, the company said. 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, respectively.

Interim data from this clinical trial were accepted and presented at the annual Association for Research in Vision and Ophthalmology (ARVO) meeting in Seattle in May 2024. According to the company, 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.