Learn about the PIONEER-1 and PIONEER-2 clinical trials in acute optic neuritis

Acute Optic Neuritis (AON) is an acute inflammation of the optic nerve that can lead to permanent visual impairment. It is a rare condition affecting up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis1.

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.

Oculis is developing Privosegtor, a novel neuroprotective candidate, to help address some of the remaining unmet medical needs in acute optic neuritis and other neuro-ophthalmology conditions.

PIONEER-1 and PIONEER-2 are registrational trials to investigate Privosegtor for the treatment of AON. PIONEER-1 is expected to initiate in Q4 2025, with PIONEER-2 planned to follow in the first half of 2026.

Learn about the PIONEER-3 clinical trial in non-arteritic anterior ischemic optic neuropathy

Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute optic nerve disorder and the most common cause of acute optic nerve injury in individuals over 50 years old2. It affects up to 10.2 per 100,000 people worldwide3 with a U.S. incidence estimated to be >30,0002,4,5.

In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies (in the retina) are permanently lost, leading to significant visual impairment or even irreversible blindness6.

There are no approved therapies for NAION and there remains an unmet medical need for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.

Oculis is developing Privosegtor, a novel neuroprotective candidate, to help address some of the remaining unmet medical needs in NAION and other neuro-ophthalmology conditions.

PIONEER-3 is a registrational trial to investigate Privosegtor for the treatment of NAION and is anticipated to start in mid-2026.

Together, we can help advance treatment options for AON and NAION.

Privosegtor is an investigational product and has not received regulatory approval for commercial use in any country. Safety and efficacy of Privosegtor for acute optic neuritis and for non-arteritic anterior ischemic optic neuropathy have not been established.

References:

1. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767. 2. https://www.aao.org/eyenet/article/naion-diagnosis-and-management 3. Kuppersmith, MJ et al. (2024): Ophthalmic and Systemic Factors of Acute Nonarteritic Anterior Ischemic Optic Neuropathy in the Quark207 Treatment Trial. 2024 July;131(7):790-802. 4. Hattenhauer M G et al. (1997): Incidence of nonarteritic anterior ischemic optic neuropathy. American Journal of Ophthalmology. 1997 Jan;123(1):103-7. 5. Lee M S et al. (2011): Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients. Ophthalmology 2011 Mar 24;118(5):959-963 6. North American Neuro-Ophthalmology Society website: https://www.nanosweb.org