Oculis (NASDAQ:OCS) announced on March 31, 2026, that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation to Privosegtor for the treatment of optic neuritis.
The designation is intended to optimize development plans and speed up the evaluation of medicines that demonstrate the potential to address significant unmet medical needs.
The EMA’s decision follows a January 2026 Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
Privosegtor also holds Orphan Drug status from both regulatory bodies, reflecting its status as a potentially transformative treatment for a condition that currently has no approved therapies to prevent permanent vision loss.
The regulatory support is underpinned by positive results from the Phase 2 ACUITY trial.
Data from that study showed significant visual, anatomical, and biological improvements in patients treated with Privosegtor.
Specifically, the therapy demonstrated a protective effect on the retinal nerve fiber layer and improved visual acuity compared to standard-of-care steroids alone.
Oculis is currently advancing its global registrational program, titled PIONEER.
The first trial in this series, PIONEER-1, was initiated in the fourth quarter of 2025.
The company aims for the PIONEER program to provide the necessary data to support formal marketing applications in both the United States and Europe.
As a TNF-alpha inhibitor delivered via eye drops, Privosegtor represents a shift toward non-invasive neuro-protective treatments in the field of ophthalmology.
Management indicated that the PRIME designation will facilitate closer interaction with EMA rapporteurs to ensure the trial design meets all necessary criteria for accelerated assessment.