Oculis Holding AG has received breakthrough therapy designation for Privosegtor, a neuroprotective candidate for optic neuropathies, potentially tapping into a $7B+ market in the U.S. The company anticipates multiple milestones from its late-stage portfolio, including topline results from Phase 3 trials with OCS-01 eye drops for diabetic macular edema in Q2 2026. CEO Riad Sherif, M.D., will present at the J.P. Morgan Healthcare Conference on January 14, 2026, discussing the transformative potential of their pipeline. Privosegtor showed promising results in the ACUITY trial, improving vision and preserving retinal and optic nerve structure. The PIONEER program aims to support registration plans for Privosegtor in optic neuritis and non-arteritic anterior optic neuropathy, targeting a market opportunity exceeding $7 billion in the U.S. alone. OCS-01, their most advanced product candidate, is in Phase 3 development for diabetic macular edema, addressing a $3 billion market opportunity in the U.S. Topline results from DIAMOND Phase 3 trials are expected in Q2 2026, with an NDA submission planned for Q4 2026.

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