Oculis' Optic Neuritis Drug Candidate Gets US FDA Breakthrough Therapy Designation

05:29 AM EST, 01/06/2026 (MT Newswires) -- The US Food and Drug Administration granted breakthrough therapy designation to Oculis' (OCS.IC) neuroprotective drug candidate for the treatment of optic neuritis, a condition that occurs when swelling damages the optic nerve. The designation for the biopharmaceutical company's Privosegtor is supported by visual‑function results from the phase 2 Acuity trial, according to a Tuesday release. In the study, patients treated with Privosegtor plus IV methylprednisolone recorded an average gain of 18 letters on the 2.5% ETDRS low-contrast letter acuity chart at three months, compared with placebo.