Regulatory Milestones: Privosegtor’s Breakthrough in Optic Neuritis Treatment

Privosegtor has received FDA Breakthrough Therapy designation for optic neuritis, accelerating development and signaling a potential first‑in‑class neuroprotective approach to limit vision loss through expedited review and prioritized FDA interactions.

Optic neuritis causes acute visual loss and is often the initial manifestation of multiple sclerosis; it produces measurable neuroaxonal injury that frequently translates into lasting visual morbidity.

Phase 2 ACUITY trial findings included an average 18‑letter gain in low‑contrast visual acuity (LCVA) at three months versus placebo plus IV methylprednisolone, alongside concordant OCT preservation and reduced neurofilament release—changes investigators interpret as consistent with reduced neuroaxonal injury and improved visual recovery.

The Breakthrough Therapy designation enables more intensive FDA engagement and eligibility for rolling and priority review. The sponsor has initiated the PIONEER program to test reproducibility and establish registration‑grade endpoints across optic neuritis and nonarteritic anterior ischemic optic neuropathy (NAION).