Oculis Holding AG (OCS) News & EventsOCSOculis Holding AG

Oculis Announces New Data from Privosegtor Trial

Oculis announced new translational biomarker data from the Phase 2 ACUITY trial of Privosegtor in patients with optic neuritis. Increases in plasma neurofilament light chain and plasma glial fibrillary acidic protein levels were reduced with Privosegtor vs. placebo, particularly at early timepoints close to acute optic neuritis onset. Together with previously observed improvements in low-contrast visual acuity with 18-letter gains at Month 3 vs. steroid alone, and preserved retinal structure, these findings provide convergent evidence across visual functional, retinal, and serum-based markers, further supporting the evaluation of Privosegtor as a potential neuroprotective therapy. Neurofilament light chain levels remained stable in the Privosegtor group through Month 6, whereas levels in the placebo group remained elevated above baseline at Month 1 before returning to baseline by Month 6. Glial fibrillary acidic protein levels remained elevated above baseline in the placebo group from Month 1 through Month 6, whereas they remained below baseline in the Privosegtor group over the same period. The late-breaking data were presented during MSToronto 2026. "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," said Riad Sherif, CEO.

Oculis Acquires Accure's Privosegtor Rights

Oculis and Accure Therapeutics announced that Oculis and Accure have entered into an asset purchase agreement whereby, upon closing, Oculis will acquire all of Accure's worldwide development and commercial rights to Privosegtor. This acquisition will result in the termination of Oculis' existing license agreement with Accure, including associated milestone payments and royalties for each successful indication. This strategic transaction would enable Oculis to better harness Privosegtor's potential value going forward, without the encumbrance of the legacy license agreement with Accure, while retaining greater economic upside for the asset's future success as the company continues to drive Privosegtor's development and pursue potential expansion opportunities. Under the terms of the agreement, upon the first closing, Oculis will acquire Accure's rights to Privosegtor and, in a separate closing, ACT-02, an early-stage preclinical neurology drug candidate. Both closings are subject to separate conditions precedent, and the ACT-02 transaction closing is dependent upon the closing of the ACT-01 transaction. Total consideration for both transactions consists of an upfront payment of $3.8M in cash, to be paid to Accure at the first closing, and up to 2,050,000 Oculis ordinary shares to be issued to Accure. The Oculis ordinary shares consist of both upfront shares subject to lockup release over a period of up to 2 years following deal completion and earnout shares subject to vesting upon achievement of development and regulatory milestones related to the assets. Oculis expects to assume, for each asset, existing license agreements with academic institutions, which include obligations to pay low single-digit percentage royalties and to preserve the academic institutions' rights to use the assets for academic and non-commercial purposes, as required under Spanish law. The agreement has been approved by Oculis' board of directors, as well as the board of directors and shareholders of Accure. The closing for Privosegtor is expected to occur no later than February 28, 2027 and the closing for ACT-02 is expected to occur no later than March 31, 2027. The first registrational trial in the program, PIONEER-1, is evaluating Privosegtor in patients following an acute onset of ON in a broad population comprising patients with and without MS. PIONEER-1 clinical site activation is advancing as planned. Oculis also recently announced positive FDA pre-IND feedback supporting a regulatory pathway for Privosegtor in acute MS relapses, ahead of a planned IND submission in the fourth quarter.

Oculis CEO Highlights Privosegtor Neuroprotection Strategy

Riad Sherif, Chief Executive Officer of Oculis, stated, "We continue to advance and expand the Privosegtor neuroprotection franchise, with PIONEER-1 on track in global site activations and positive regulatory momentum supporting our development strategy in acute multiple sclerosis relapses. Given the considerable unmet need for neuroprotective treatments, these achievements reinforce both our strategy to pivot to neuro-ophthalmology by exploring the clinical potential of Privosegtor and the substantial opportunity across multiple neuro-ophthalmic and neuro-axonal diseases. In parallel, with Licaminlimab PREDICT-1 genotype-based trial planned site activations complete and over 45% of patients enrolled, we expect to report topline results around year-end. With a strong balance sheet, we are well positioned to execute on our strategy, advance our registrational programs and deliver on upcoming value-driving milestones."