Biopharmaceutical company Oculis Holding AG (Nasdaq:OCS) (ICX:OCS.IC) on Monday announced positive topline results from the Phase 2 ACUITY trial evaluating OCS-05 in acute optic neuritis.

The trial met the primary safety endpoint and demonstrated statistically significant improvements on key secondary efficacy endpoints, including measures of retinal thickness and visual function.

Acute optic neuritis is a rare condition affecting the optic nerve, often an early sign of multiple sclerosis. The ACUITY trial evaluated OCS-05 in patients with recent onset of unilateral acute optic neuritis.

OCS-05, a neuroprotective candidate, has received orphan drug designation from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for acute optic neuritis. There are currently no approved therapies specifically indicated for this condition.

The FDA has cleared the Investigational New Drug application for OCS-05, enabling the initiation of clinical development in the United States. Oculis plans to further evaluate OCS-05 as a potential first-in-class neuroprotective therapy for acute optic neuritis and explore its potential in other neurodegenerative diseases.