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Oculis Holding AG (NASDAQ:OCS) ("Oculis"), a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic diseases with significant unmet medical needs, today announces the advancement of Privosegtor into a registrational program for neuro-ophthalmology indications following a positive meeting with the U.S. Food and Drug Administration (FDA).
Privosegtor is a new peptoid small molecule candidate with the potential to become the first neuroprotective therapy for acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potential in other neuro-ophthalmic and neurological diseases. Following FDA feedback, the company is starting the PIONEER program this year, which will include three pivotal trials to support registration plans for Privosegtor in AON and NAION.
The first two trials, PIONEER-1 and PIONEER-2, will evaluate Privosegtor following the acute onset of optic neuritis in a broad population consisting of patients with multiple sclerosis (MS) and those without MS. The primary endpoint will be measured as low-contrast visual acuity (LCVA) at 3 months. Dosing and patient enrollment criteria will mirror those of the positive Phase 2 ACUITY trial, which demonstrated improvement in visual function and anatomical preservation of the retina in patients with AON. PIONEER-1 is expected to initiate in Q4 2025, with PIONEER-2 planned to follow in the first half of 2026.
The FDA provided guidance that Privosegtor can be evaluated in other neuro-ophthalmology indications, such as NAION, under the current IND. The third trial in the PIONEER program, PIONEER-3, will evaluate Privosegtor after the acute onset of NAION. This study shares the core design and operational elements with PIONEER-1 and PIONEER-2, and is expected to begin in mid-2026. Running these three studies concurrently is expected to generate operational synergies, cost efficiencies, and speed up development timelines.
AON and NAION are two rare neuro-ophthalmic diseases with high unmet medical needs for a therapy that can provide neuroprotection and preserve vision. AON is often the first clinical symptom of multiple sclerosis. While corticosteroids are used to treat inflammation in AON, there are no approved neuroprotective therapies that can restore vision for patients suffering from acute optic neuritis. Likewise, no medical or surgical treatment has been shown to improve the prognosis in cases of acute NAION.
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