Trial Profile

PIONEER-1: A global pivotal study of Privosegtor for the treatment of acute onset of optic neuritis in a broad population consisting of patients with and without multiple sclerosis (MS)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 12 Nov 2025

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At a glance

12 Nov 2025 New trial record
06 Oct 2025 According to Oculis pharma media release, dosing and patient enrollment criteria in PIONEER-1 and PIONEER-2 studies will mirror those of the positive Phase 2 ACUITY trial.
06 Oct 2025 According to Oculis pharma media release, following a positive meeting with the USFDA, the company is ready to advance Privosegtor into a registrational program for neuro-ophthalmology indications. Following FDA feedback, the company is starting PIONEER program this year, which will include 3 pivotal trials (PIONEER-1, 2 and 3) to support registration plans for Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

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