Oculis (OCS) investor relations material

Pipeline and Clinical Development

• Three late-stage assets—OCS-01 (DME), Licaminlimab (dry eye), and Privosegtor (neuroprotection)—are advancing through registrational and pivotal trials, with multiple readouts and submissions planned over the next 24 months.

• OCS-01 is the first non-invasive eye drop for DME, with DIAMOND 1 & 2 Phase 3 trials; topline results expected in Q2, NDA submission in Q4, and approval targeted for 2027.

• Licaminlimab uses a biomarker-driven, genotype-based approach for dry eye, with phase III readout in Q4 2026 and smaller, more efficient trials.

• Privosegtor, a first-in-class neuroprotective agent, is in phase III trials for optic neuritis and NAION, with breakthrough therapy designation and expansion plans into MS relapse treatment.

• Pipeline expansion includes broader neuro-axonal disease indications, with MS relapses IND planned for 2H 2026.

Clinical Results and Differentiation

• OCS-01 demonstrated significant BCVA improvement, rapid retinal edema reduction, and a favorable safety profile in both treatment-naive and previously treated DME patients.

• Licaminlimab showed five- to sevenfold better efficacy in biomarker/genotype-positive patients, enabling targeted and cost-effective development.

• Privosegtor preserved neurons, axons, and myelin in preclinical and clinical studies, with phase II data showing improved vision, reduced axonal damage, and no drug-related serious adverse events.

• Privosegtor is positioned as the first effective neuroprotective therapy in its indications, addressing large unmet needs.

• ACUITY trial for Privosegtor showed sustained LCVA improvement and reduced neurofilament levels.

Market Opportunity and Commercialization

• OCS-01 targets the 1.8 million diagnosed DME patients in the U.S., with half untreated, focusing on early intervention and non-responders.

• Privosegtor's initial optic neuropathies market is estimated at $7 billion, with potential expansion to all MS relapses (170,000-180,000 events/year in the U.S.).

• OCS-01, Licaminlimab, and Privosegtor address multi-billion-dollar markets with significant unmet needs, and expansion into additional neuro-axonal diseases could increase the addressable market by $50B.

• Commercial strategy includes direct U.S. launches, ex-U.S. partnerships, and openness to out-licensing.

• Rapid adoption is expected for OCS-01 due to high unmet need and physician enthusiasm, as shown by fast U.S. trial enrollment.