Oculis announced that its neuroprotective candidate Privosegtor has been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the treatment of optic neuritis (ON). The EMA’s PRIME designation is reserved for a limited number of therapies each year that demonstrate the potential to address significant unmet medical needs and offer meaningful advantages over existing treatments. The designation follows the FDA's Breakthrough Therapy designation granted to Privosegtor in January 2026. Privosegtor has also received Orphan Drug designation from both agencies for ON. Privosegtor is a novel peptoid small molecule capable of crossing both the blood-brain and retinal barriers, positioning it as a potential first-in-class neuroprotective therapy for optic neuropathies. These conditions can result in permanent vision loss due to irreversible nerve cell damage, and currently lack approved neuroprotective treatment options. Clinical Data Supports Regulatory Momentum The EMA’s decision is supported by results from the phase 2 ACUITY trial, which evaluated Privosegtor in patients with optic neuritis. In the study, treatment with Privosegtor in combination with steroids demonstrated: Significant improvement in low-contrast visual acuity (LCVA) Consistent anatomical and biological benefits compared to placebo plus steroids These findings suggest a clinically meaningful neuroprotective effect and were considered by the EMA to be aligned with a magnitude of benefit capable of addressing the unmet need in ON. Oculis is advancing Privosegtor through its PIONEER program, a global registrational effort that includes three clinical trials targeting optic neuritis and another rare neuro-ophthalmic condition, non-arteritic anterior ischemic optic neuropathy (NAION). The first study in the program, PIONEER-1, was initiated in the fourth quarter of 2025, with site activation progressing as planned. “EMA’s decision to grant PRIME designation highlights Privosegtor’s compelling results and its potential as a first-in-class neuroprotective therapy for people experiencing optic neuritis,” said Riad Sherif, MD, CEO of Oculis. “Despite the current use of corticosteroids to shorten the inflammatory attack after an acute episode, there remains an unmet need for therapies that can prevent vision loss through neuroprotection. Through our PIONEER registrational program, we look forward to advancing Privosegtor globally and redefining what’s possible for patients.” The EMA’s PRIME designation provides early and enhanced regulatory support, including optimized development guidance and the potential for accelerated review.