Oculis Secures FDA Backing and Full Ownership of Privosegtor

Oculis Holding AG, a Zug-based biopharmaceutical company with operations in Lausanne, has had a decisive first two weeks of August 2026, combining positive US regulatory feedback with a strategic acquisition that together strengthen its position in neuro-ophthalmology.

Positive FDA pre-IND feedback for acute MS relapses

On August 3, Oculis announced that the FDA’s Division of Neurology had given positive pre-IND feedback on a regulatory pathway for Privosegtor, the company’s novel neuroprotective peptoid candidate, in acute multiple sclerosis (MS) relapses. The FDA confirmed that Oculis can cross-reference existing Privosegtor data from its open IND, meaning no additional preclinical studies are required before filing. An IND submission for this new indication is planned for the fourth quarter of 2026.

The move builds on Privosegtor’s Phase 2 ACUITY results in optic neuritis — a common type of MS relapse — where the candidate improved visual function, preserved retinal ganglion cell integrity, and reduced neurofilament levels, a marker of axonal injury. “Building on positive Phase 2 ACUITY data in optic neuritis, we believe Privosegtor has the potential to mitigate neuroaxonal damage and improve recovery following acute relapse events,” said Riad Sherif, M.D., CEO of Oculis. MS affects an estimated 2.8 million people worldwide, with around 170,000 relapses occurring each year in the US alone, and no neuroprotective therapy is currently approved for this indication.

Full acquisition of Privosegtor from Accure Therapeutics

One week later, on August 10, Oculis announced an asset purchase agreement with Barcelona-based Accure Therapeutics to acquire full worldwide development and commercial rights to Privosegtor, terminating the companies’ existing license agreement along with its associated milestone payments and royalties. The deal also includes ACT-02, an early-stage preclinical neurology candidate from Accure, in a separate closing.

Consideration for both assets totals a $3.8 million upfront cash payment plus up to 2,050,000 Oculis ordinary shares, subject to lockup release over two years or vesting on development and regulatory milestones. Closing for Privosegtor is expected by February 28, 2027, and for ACT-02 by March 31, 2027. “By terminating our legacy license agreement with Accure, we can secure global commercial rights to this unique, long-term asset at significantly reduced royalties as we build a leadership position in neuro-ophthalmology,” said Sherif.

Together, the two announcements give Oculis clearer ownership economics and a widening regulatory runway for Privosegtor, which is already advancing through the pivotal PIONEER-1 trial in optic neuritis. The Swiss Health Valley company plans to host an R&D Day in the fourth quarter of 2026 to share further details on both programmes.

➡️ Source: Press Release | 📸 ©Oculis