Oculis announced that its OCS-01 eye drops failed to meet the primary endpoint of improving visual acuity in two Phase 3 trials for diabetic macular edema (DME), though secondary endpoints showed significant retinal thickness reduction. The company will not pursue FDA approval for OCS-01 for DME and will redirect resources toward its PIONEER trial for Privosegtor and PREDICT-1 trial for Licaminlimab.

Oculis announced that its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops failed to meet the primary endpoint of improved best corrected visual acuity (BCVA) in diabetic macular edema patients at week 52, despite showing substantial retinal thickness reduction. The company will not pursue FDA filing for OCS-01 in DME and will redirect resources to its Privosegtor and Licaminlimab programs. Oculis maintains a strong financial position with $278 million in cash runway into 2H 2029.

Oculis received FDA approval for a Special Protocol Assessment (SPA) agreement for PIONEER-1, a Phase 3 registrational trial evaluating Privosegtor for optic neuritis treatment. The agreement validates the trial design and planned analysis for future NDA submission. Privosegtor previously received FDA Breakthrough Therapy and EMA PRIME designations, with Phase 2 ACUITY trial showing substantial vision improvements and favorable safety profile.

Oculis announced it has received FDA approval for a Special Protocol Assessment (SPA) agreement for PIONEER-1, a Phase 3 registrational trial evaluating Privosegtor for optic neuritis treatment. The SPA confirms the trial design is adequate to support a future NDA submission. Privosegtor previously received FDA Breakthrough Therapy and EMA PRIME designations, addressing a significant unmet medical need in a potential $7 billion U.S. market.

Oculis announced findings from the DME AWARE Delphi study presented at ARVO 2026, highlighting unmet needs in diabetic macular edema (DME) management. The study confirms strong expert consensus for non-invasive treatment options for early intervention. Oculis is on track to report topline results in June 2026 from its DIAMOND Phase 3 trials with OCS-01, aiming to be the first eye drop therapy for DME.

Oculis announced findings from the DME AWARE Delphi study highlighting unmet needs in diabetic macular edema (DME) management, particularly the need for non-invasive treatment options for early intervention. The study, presented at ARVO 2026, found that 60% of DME patients remain untreated one year after diagnosis due to invasive current therapies, and 40% of anti-VEGF treated patients show inadequate response. Oculis is on track to report Phase 3 results for OCS-01, a potential first-in-class eye drop therapy for DME, in June 2026.

Oculis announced it will present at the ARVO 2026 Annual Meeting, highlighting its late-stage pipeline including OCS-01 eye drops for diabetic macular edema with Phase 3 topline results anticipated in June 2026, Privosegtor for optic neuropathies, and Licaminlimab for dry eye disease. The company will showcase recent regulatory milestones and clinical data demonstrating the transformative potential of its therapies.

Oculis announced it will present at the ARVO 2026 Annual Meeting, highlighting its late-stage pipeline including OCS-01 eye drops for diabetic macular edema with Phase 3 topline results anticipated in June 2026, Privosegtor for optic neuropathies, and Licaminlimab for dry eye disease. The company will showcase recent regulatory milestones and clinical data demonstrating the transformative potential of its ophthalmology and neuro-ophthalmology candidates.

Oculis Holding AG announced participation in upcoming investor conferences in April 2026, highlighting a landmark year with multiple pivotal readouts expected. Key milestones include OCS-01 Phase 3 topline results for diabetic macular edema in June 2026, Licaminlimab registrational trial results for dry eye disease in late 2026, and Privosegtor receiving both FDA Breakthrough Therapy and EMA PRIME designations for optic neuritis treatment. The company expects to deliver 6 pivotal readouts with current funding.

Oculis announced that its neuroprotective candidate Privosegtor has received Priority Medicines (PRIME) designation from the European Medicines Agency for treating optic neuritis. This follows the FDA's Breakthrough Therapy designation in January 2026. The designation is supported by positive Phase 2 ACUITY trial data showing improvements in vision and neuroprotective benefits. Oculis is advancing the PIONEER registrational program with trials in optic neuropathies.

Oculis announced that its neuroprotective candidate Privosegtor received Priority Medicines (PRIME) designation from the European Medicines Agency for treating optic neuritis. This follows the FDA's Breakthrough Therapy designation in January 2026. The company is advancing the PIONEER registrational program with positive Phase 2 ACUITY trial data showing improvements in vision and neuroprotective benefits. Privosegtor has potential to become the first neuroprotective therapy for optic neuropathies, addressing a $7 billion market opportunity.

Oculis announced the presentation of Phase 2 ACUITY trial results for Privosegtor, a neuroprotective therapy for optic neuritis, at the North American Neuro-Ophthalmology Society's 52nd Annual Meeting on March 23, 2026. The trial demonstrated improved low-contrast visual acuity and reduction in retinal ganglion cell loss. Privosegtor has received FDA Breakthrough Therapy designation and the company is advancing the PIONEER registrational program, with PIONEER-1 trial initiated in Q4 2025.