Swiss company Oculis announced Oct. 6 that it will advance Privosegtor into a pivotal program for two indications in neuro-ophthalmology following a positive meeting with the US FDA.

Privosegtor is a peptoid small molecule candidate for intravenous injection. The Phase II ACUITY trial showed Privosegtor’s potential neuroprotective effects through anatomical preservation of the retina and visual function improvements after an acute episode of optic neuritis.

The company said it will soon begin pivotal trials in both acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION):

—PIONEER-1 in AON (Q4-2025)

—PIONEER-2 in AON (H1-2026)

—PIONEER-3 in NAION (mid-2026)

PIONEER-1 and PIONEER-2 will evaluate Privosegtor following the acute onset of optic neuritis in patients with multiple sclerosis (MS) and those without. AON is often the first clinical symptom of MS. The primary endpoint is low-contrast visual acuity at three months.

PIONEER-3 will evaluate Privosegtor after the acute onset of NAION.

While corticosteroids are used to treat inflammation in AON, there are no approved neuroprotective therapies that can restore vision for patients. Likewise, no medical or surgical treatment has been shown to improve the prognosis in cases of acute NAION, Oculis said.

Oculis is also advancing topical candidates for dry eye and diabetic macular edema.

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