Key Takeaways

  • FDA pre-IND feedback supports Oculis' planned clinical development of Privosegtor for acute MS relapses, with an IND submission anticipated in the fourth quarter of 2026
  • Oculis is pursuing a dual development approach by advancing the registrational PIONEER program in optic neuritis while expanding Privosegtor into the broader acute MS relapse setting

Oculis announced that it has received positive pre-investigational new drug (pre-IND) feedback from the FDA supporting the planned clinical development of Privosegtor for the treatment of acute multiple sclerosis (MS) relapses.

The company said the FDA's Division of Neurology indicated that Oculis may cross-reference data from its existing open IND for Privosegtor and that no additional preclinical studies will be required before submitting an IND for the new indication. Oculis plans to submit the IND application in the fourth quarter of 2026.

According to the company, the agency also supported key elements of the proposed development strategy, including enrolling patients experiencing optic neuritis as well as other ambulatory MS relapses, using a primary endpoint at 3 months, and administering Privosegtor at a dose of 3 mg/kg daily for 5 days, consistent with the ongoing PIONEER-1 trial.

Privosegtor is an investigational peptoid small-molecule candidate designed to provide neuroprotection. The program builds on findings from the completed phase 2 ACUITY trial in optic neuritis, where the therapy demonstrated improvements in visual function while preserving retinal ganglion cell layer integrity and reducing neurofilament levels, a biomarker associated with axonal injury.

Optic neuritis is frequently associated with new-onset MS and acute MS relapses and is considered a clinically relevant model for studying neuroprotection in inflammatory demyelinating disease. The ACUITY study enrolled patients with optic neuritis both with and without MS, providing the foundation for the company's ongoing registrational PIONEER program in optic neuritis and supporting expansion into broader MS relapse indications.

"Our recent positive engagement with the FDA supports a regulatory pathway for Privosegtor in acute MS relapses, an area of high unmet need with no currently approved neuroprotective options," said Riad Sherif, MD, chief executive officer of Oculis. "Building on positive phase 2 ACUITY data in optic neuritis, a frequent type of MS relapse, we believe Privosegtor has the potential to mitigate neuroaxonal damage and improve recovery following acute relapse events."

Dr. Sherif added that the regulatory milestone advances the company's strategy to expand its neuro-ophthalmology pipeline and that additional details regarding both the PIONEER program and the MS relapse development plan will be presented during an R&D Day planned for the fourth quarter of 2026.