Oculis Secures U.S. FDA Breakthrough Therapy Designation for Privosegtor in Optic Neuritis Treatment

Oculis Holding AG (Nasdaq: OCS / XICE: OCS), a global biopharmaceutical company focused on neuro‑ophthalmic and ophthalmic innovations, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its investigational candidate Privosegtor for the treatment of optic neuritis (ON), a rare, vision‑threatening condition often associated with multiple sclerosis. Privosegtor is a novel peptoid small molecule engineered to cross both the blood–brain and retinal barriers, with the potential to become the first neuroprotective therapy for optic neuropathies, addressing significant unmet medical needs where no such treatments currently exist. The FDA designation was supported by compelling Phase 2 ACUITY clinical trial data, which showed an average gain of 18 letters in low‑contrast visual acuity (LCVA) at three months when Privosegtor was administered with standard steroid therapy, surpassing clinically meaningful thresholds and demonstrating associated anatomical and biological benefits versus placebo. Oculis has also initiated its PIONEER registrational program, encompassing three pivotal trials to support future approval plans for Privosegtor in ON and non‑arteritic anterior ischemic optic neuropathy (NAION). Enrollment is expected to begin soon at global sites, and the company highlights a potential U.S. market opportunity exceeding $7 billion, reflecting the high unmet need in these serious optic nerve diseases. Executives from Oculis noted that this milestone positions Privosegtor as a promising neuroprotective candidate poised to reshape treatment landscapes for optic neuropathies and potentially other neurological conditions. #Oculis #Privosegtor #OpticNeuritis #FDABreakthrough #SlimScan #GrowthStocks #CANSLIM