Oculis Announces European Medicines Agency PRIME Designation for Privosegtor

Oculis Holding AG, based in canton of Vaud and Zug, has received a significant regulatory boost for its neuroprotective candidate Privosegtor, with the European Medicines Agency (EMA) granting the therapy Priority Medicines (PRIME) designation for the treatment of optic neuritis (ON).

Optic neuritis is a rare and sight-threatening condition that can occur as a relapse of multiple sclerosis or serve as its first clinical manifestation. The disease can lead to lasting vision damage, and treatment options remain limited.

Privosegtor is a novel peptoid small molecule designed to cross both the blood-brain barrier and the retinal barrier, positioning it as a potential first-in-class neuroprotective therapy for optic neuropathies. These disorders currently have no approved neuroprotective treatments, despite their potential to cause permanent visual impairment due to nerve cell damage and death.

The EMA’s decision, reserved for a small number of highly promising therapies each year, follows the U.S. FDA’s Breakthrough Therapy designation, awarded to Privosegtor in January 2026, further strengthening regulatory momentum for the programme. The decision was supported by data from the Phase 2 ACUITY trial, where Privosegtor used in combination with steroids demonstrated meaningful improvement in low-contrast visual acuity (LCVA), along with consistent anatomical and biological benefits compared with placebo plus steroids. According to Oculis, these findings suggest the therapy may significantly improve outcomes for patients with optic neuritis.

Building on these results, Oculis is advancing its PIONEER registrational programme, which includes three global late-stage trials in optic neuritis and non-arteritic anterior ischemic optic neuropathy (NAION), another rare neuro-ophthalmic disease. The first trial, PIONEER-1, was launched in Q4 2025, and site activation is ongoing.

Commenting on the milestone, Riad Sherif, M.D., Chief Executive Officer of Oculis, said the designation highlights Privosegtor’s potential to become a first-in-class treatment for patients facing acute optic neuritis and the risk of irreversible vision loss. The drug could also have wide applicability in treating other neuro-ophthalmic and neurological indications.

In addition to PRIME and Breakthrough Therapy designations, Privosegtor has also received Orphan Drug designation from both the EMA and the FDA for optic neuritis.

➡️ Source: Press Release | 📸 Oculis