Oculis has announced positive topline results for its phase 2 ACUITY trial of OCS-05, a neuroprotective therapy candidate for acute optic neuritis. The trial met its primary safety endpoint and demonstrated statistically significant improvements in retinal structure and visual function, signaling potential for a first-in-class treatment.

The ACUITY trial (NCT04762017) evaluated 33 patients in a randomized, double-blind, placebo-controlled format. OCS-05, administered intravenously alongside steroids, improved ganglion cell-inner plexiform layer (GCIPL) and retinal nerve fiber layer (RNFL) thickness by 43% and 30%, respectively, at six months. Visual function improvements were also observed, with patients gaining an average of 15 additional low-contrast letters on an acuity test compared to placebo.

Safety was confirmed, with no serious adverse events reported and side effects limited to mild, transient issues like headaches. These findings support Oculis’s plans to expand clinical development globally, including in the United States, where OCS-05 recently received investigational new drug clearance from the FDA.