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REG-Oculis Reports New Phase 2 ACUITY Biomarker Data  Further Supporting Privosegtor’s Neuroprotective Potential in Optic Neuritis

Globe Newswire•22/10/2026•02:00 ET
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Key Highlights

  • ➤Privosegtor reduced post-onset plasma NfL increases versus placebo in Phase 2 ACUITY
  • ➤Privosegtor reduced post-onset plasma GFAP increases versus placebo in Phase 2 ACUITY
  • ➤Prior ACUITY results showed +18-letter Month 3 low-contrast visual acuity gains
  • ➤Oculis is advancing Privosegtor in the PIONEER registrational program
  • ➤Oculis plans an IND submission for Privosegtor in acute MS relapses

Expert Statements

Céline Louapre, Professor of Neurology at Pitié-Salpêtrière Hospital, Sorbonne University, and presenting author

“These findings are particularly noteworthy because they provide biological evidence that complements the functional and retinal structural improvements previously observed in ACUITY. The consistent effects across NfL and GFAP suggest that Privosegtor may be influencing multiple pathways involved in tissue injury following acute optic neuritis, supporting its potential as a neuroprotective therapeutic approach. Together, these data deepen our understanding of the treatment's effects and further support continued clinical evaluation.”

Riad Sherif, Chief Executive Officer of Oculis

“For patients with optic neuritis, irreversible neuro-axonal damage can occur within days of disease onset, yet there are currently no approved therapies designed to protect retinal ganglion cells and their axons, the neurons responsible for transmitting visual signals from the eye to the brain, and preserve long-term visual function. These biomarker findings and translational analyses provide important additional evidence supporting Privosegtor’s neuroprotective potential, strengthening our confidence as we advance the PIONEER registrational program and explore its broader applicability across acute neuro-axonal conditions, including acute multiple sclerosis relapses.”

Privosegtor reduced post-onset increases in plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) compared with placebo

Lower NfL and GFAP levels provide objective, complementary biological evidence of reduced neuroaxonal injury and suppressed reactive astrogliosis

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