The company said existing data can support a new IND filing planned for the fourth quarter of 2026, extending its neuroprotective candidate beyond optic neuritis.
Oculis said the FDA (U.S. drug regulator) gave positive pre-IND feedback on Privosegtor for acute multiple sclerosis relapses, supporting a regulatory pathway that would let the company cross-reference existing data and avoid additional preclinical studies before a planned fourth-quarter 2026 IND submission. The feedback backs a development strategy that would test MS patients with optic neuritis and other relapse types, including ambulatory relapses, using a primary endpoint as early as 3 months and the same 3mg/kg dose given daily for 5 days as in PIONEER-1. Privosegtor, a peptoid small-molecule candidate with neuroprotective potential, is already being advanced in Oculis’ registrational PIONEER program for optic neuropathies after Phase 2 ACUITY data in optic neuritis showed improved visual function, preservation of retinal ganglion cell layer integrity, and lower neurofilament levels, a biomarker of axonal injury. Oculis plans to host an R&D Day in the fourth quarter of 2026 to outline the acute MS relapse program and update investors on PIONEER. The company frames the expansion as a response to a major unmet need, with no approved neuroprotective therapies for MS relapses despite an estimated 170,000 relapses each year in the U.S.