Oculis kynnir ný lífmerkisgögn (e. Biomarker Data) úr fasa 2 ACUITY-rannsókninni sem styðja enn frekar taugaverndandi möguleika Privosegtor við sjóntaugabólgu

Oculis announced new biomarker data from the Phase 2 ACUITY trial showing that Privosegtor reduced increases in neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) in blood compared to placebo in optic neuritis patients. The data supports earlier findings of improved low-contrast visual acuity and retinal structure preservation, suggesting Privosegtor's neuroprotective effects. The company plans to continue the PIONEER registration program and explore applications in acute MS relapses.

10/22/2026, 2:00 AM • GlobeNewswire

Oculis Reports New Phase 2 ACUITY Biomarker Data  Further Supporting Privosegtor’s Neuroprotective Potential in Optic Neuritis

Oculis announced Phase 2 ACUITY trial biomarker data showing Privosegtor reduced plasma neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) levels compared to placebo in optic neuritis patients. The results provide objective evidence of reduced neuroaxonal injury and suppressed neuroinflammation, complementing previously reported functional improvements of +18-letter gains in low-contrast visual acuity and retinal preservation at Month 3. These findings support continued development of Privosegtor for acute optic neuritis and acute MS relapses.

10/22/2026, 2:00 AM • GlobeNewswire

Oculis to Present Late-Breaking Phase 2 ACUITY Biomarker Analyses of Privosegtor in Optic Neuritis at the 10th Joint ACTRIMS-ECTRIMS Meeting

Oculis announced it will present new biomarker data from its Phase 2 ACUITY trial of Privosegtor at the 10th Joint ACTRIMS-ECTRIMS Meeting in Toronto on October 21-23, 2026. The presentation will highlight plasma NfL and GFAP biomarker analyses demonstrating neuroprotective potential in acute optic neuritis patients. Privosegtor has received FDA Breakthrough Therapy and EMA PRIME designations, with the company planning registrational trials through its PIONEER program.

10/20/2026, 2:00 AM • GlobeNewswire

Oculis lýkur slembiröðun í PREDICT-1 skráningarrannsókninni á Licaminlimab við TNFR1-miðluðum augnþurrki

Oculis announced completion of randomization in the PREDICT-1 registrational trial for Licaminlimab, a precision medicine treatment for TNFR1-mediated dry eye disease. The trial enrolled 176 patients, with two-thirds carrying the specific TNFR1 genetic variant associated with improved clinical response. Topline results are expected around year-end 2026. If approved, Licaminlimab could become the first precision medicine treatment for an estimated 1.5 million Americans with moderate to severe TNFR1-mediated dry eye disease.

10/19/2026, 2:00 AM • GlobeNewswire

Oculis to Highlight Licaminlimab at Eyecelerator @ AAO 2026 and Partner with Neuro-Ophthalmology Subspecialty Day

Oculis announced that CEO Riad Sherif will present Licaminlimab, a novel topical anti-TNFα candidate for TNFR1-mediated dry eye disease, at Eyecelerator @ AAO 2026 on October 8. The company's PREDICT-1 registrational trial is on track for topline readout around year-end. Oculis will also sponsor the Neuro-Ophthalmology Subspecialty Day, highlighting its commitment to advancing neuro-ophthalmology research and innovation.

10/07/2026, 2:00 AM • GlobeNewswire

Oculis to Present Privosegtor at Upcoming Clinical Trials at the Summit 2026

Oculis announced a presentation at Clinical Trials at the Summit 2026 on its investigational drug Privosegtor, a neuroprotective therapy candidate for optic neuritis. The company highlighted positive Phase 2 ACUITY trial results and regulatory milestones including FDA Breakthrough Therapy designation and EMA PRIME designation, as it advances the PIONEER registrational program.

06/11/2026, 4:00 AM • GlobeNewswire

Oculis to Present Privosegtor at Upcoming Clinical Trials at the Summit 2026

Oculis Holding AG announced it will present Privosegtor, a novel neuroprotective therapy candidate, at Clinical Trials at the Summit 2026 on June 13, 2026. The presentation will highlight Privosegtor's development journey from discovery through the PIONEER registrational trials for optic neuritis treatment. The drug has received Breakthrough Therapy and PRIME designations and showed positive Phase 2 ACUITY trial results.

06/11/2026, 4:00 AM • GlobeNewswire

OCS Investors Have Opportunity to Join Oculis Holding AG Fraud Investigation with the Schall Law Firm

The Schall Law Firm is investigating Oculis Holding AG for potential securities law violations. The company previously stated its Phase 3 DIAMOND trials were 'advancing as planned,' but announced on May 29, 2026, that both trials failed to meet primary endpoints, leading to the decision not to pursue FDA filing for its drug candidate. Investors are invited to join the class action lawsuit.

06/04/2026, 4:31 PM • Benzinga

Íslensk þýðing á fyrri tilkynningu; Oculis tilkynnir um helstu niðurstöður úr fasa 3 DIAMOND rannsóknunum á OCS-01 við sjónhimnubjúg af völdum sykursýki

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.

05/29/2026, 3:54 PM • GlobeNewswire

Oculis Announces Topline Results from DIAMOND Phase 3 Trials with OCS-01 in Diabetic Macular Edema

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.

05/29/2026, 2:52 PM • GlobeNewswire

Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial

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.

05/07/2026, 5:00 AM • GlobeNewswire

Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial

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.

05/07/2026, 4:57 AM • GlobeNewswire

Latest Findings from DME AWARE Delphi Study Presented at ARVO 2026 Annual Meeting

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.

05/05/2026, 4:00 AM • GlobeNewswire

Latest Findings from DME AWARE Delphi Study Presented at ARVO 2026 Annual Meeting

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.

05/05/2026, 4:00 AM • GlobeNewswire

Oculis to Present at Upcoming Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

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.

05/01/2026, 4:00 AM • GlobeNewswire