TORONTO – New clinical data from Oculis Holding AG (Nasdaq: OCS) is set to take center stage at the 10th Joint ACTRIMS-ECTRIMS Meeting in Toronto, as the biopharmaceutical company unveils critical findings regarding its investigational drug, Privosegtor. The presentation, scheduled for Thursday, October 22, will provide a detailed look at how the novel therapy influences specific biological markers of neuroaxonal injury in patients suffering from acute optic neuritis (ON).
Optic neuritis, a condition often serving as a precursor to multiple sclerosis, involves the acute inflammation of the optic nerve. Without approved neuroprotective therapies, patients currently face a high risk of permanent retinal ganglion cell loss and irreversible visual impairment.
The upcoming late-breaking presentation, titled “Effect of Privosegtor on Plasma Neurofilament-Light and Glial Fibrillary Acidic Protein Levels in the Phase 2 ACUITY Trial,” will be delivered by Professor Céline Louapre of the Pitié-Salpêtrière Hospital. The session promises to reveal how Privosegtor impacts plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP)—two primary indicators of neuroinflammation and central nervous system damage.
“Optic neuritis and demyelinating relapses represent a high-stakes clinical race against permanent neuro-axonal loss and irreversible functional deficits,” said Riad Sherif, M.D., Chief Executive Officer of Oculis. “With no approved neuroprotective therapies currently available to protect retinal ganglion cells and their axons, deep translational analyses are vital to advancing care.”
The data stems from the Phase 2 ACUITY trial, which previously demonstrated the drug’s potential to preserve visual function and anatomical integrity of the retina. Following these positive results, Privosegtor has secured significant regulatory momentum, receiving Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the EMA.
Oculis is currently advancing its PIONEER program, a series of registrational trials evaluating the drug’s efficacy in broader optic neuropathy populations, including patients both with and without multiple sclerosis. The company has also signaled its intent to file an Investigational New Drug (IND) application to test Privosegtor’s efficacy in treating acute multiple sclerosis relapses.
The medical community is expected to closely monitor the findings, as the potential for a first-in-class neuroprotective agent could fundamentally alter the treatment landscape for neuro-ophthalmic diseases. Oculis plans to provide further updates on its late-stage pipeline during an R&D Day scheduled for December 8, 2026.
For now, the spotlight remains on Toronto, where clinicians and researchers gather to evaluate whether these biomarkers confirm that Privosegtor can effectively interrupt the cascade of nerve cell death. As it stands, Privosegtor remains an investigational candidate and has not yet received regulatory approval for commercial use.
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