Oculis Holding AG (NASDAQ:OCS) shares climbed today after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Privosegtor (OCS-05), a first-in-class neuroprotective candidate for the treatment of optic neuritis.
The designation, announced January 6, 2026, marks a major milestone for the Swiss biotech as it targets a $7 billion U.S. market for optic neuropathies.
The FDA’s decision is backed by robust data from the Phase 2 ACUITY trial, which demonstrated that Privosegtor significantly outperforms standard care.
Patients treated with the novel peptoid small molecule alongside intravenous (IV) steroids saw an average gain of 18 letters in Low Contrast Visual Acuity (LCVA) at month three—an outcome that far exceeds the results seen with steroids alone.
Beyond functional vision gains, the trial showed structural neuroprotection, including 43% better preservation of the retinal ganglion cell layer and a reduction in the release of neurofilaments, a key biomarker of nerve damage.
Oculis is now moving rapidly into the registrational phase with its global PIONEER program, which consists of three pivotal trials.
The first, PIONEER-1, was initiated in the fourth quarter of 2025 and is currently activating global sites for enrollment.
Unlike current treatments that only manage the inflammation associated with optic neuritis, Privosegtor is designed to cross both the blood-brain and retinal barriers to directly prevent nerve cell death.
If approved, it would become the first-ever neuroprotective therapy for the condition, which is often the first clinical sign of multiple sclerosis.