Swiss-based biopharmaceutical company Oculis Holding AG (NASDAQ: OCS; XICE: OCS) announced on Tuesday that its neuroprotective candidate Privosegtor has received Breakthrough Therapy Designation from the US Food and Drug Administration for the treatment of optic neuritis.

The designation is supported by Phase 2 ACUITY trial data, in which Privosegtor achieved an average gain of 18 letters in low contrast visual acuity at three months when added to intravenous methylprednisolone, compared with steroid treatment alone.

Privosegtor is a peptoid small molecule designed to cross the blood-brain and retinal barriers and is intended to address optic neuropathies, conditions for which no neuroprotective treatments are currently approved and which represent a potential US market of about USD7bn.

Following a meeting with the FDA in 2025, Oculis launched the registrational PIONEER programme, comprising three pivotal trials in optic neuritis and non-arteritic anterior ischaemic optic neuropathy. The first study, PIONEER-1 in optic neuritis, was initiated in the fourth quarter of last year, spans three continents and is progressing towards patient enrolment.