Oculis Holding AG reports news on a late-stage ophthalmology and neuro-ophthalmology pipeline focused on eye and optic-nerve disorders with unmet medical need. Company updates commonly cover OCS-01 eye drops for diabetic macular edema, Privosegtor for optic neuritis and other optic neuropathies, and Licaminlimab, a topical anti-TNFα candidate being developed for dry eye disease with a genotype-based approach.
Recurring developments include clinical-program updates, FDA and EMA regulatory interactions, scientific meeting presentations, pipeline reviews, financial results, capital-market communications, annual general meeting materials, and notifications of managerial transactions. Oculis is a Swiss biopharmaceutical company with ordinary shares traded on Nasdaq and Nasdaq Iceland under OCS.
Oculis (OCS) has completed randomization in PREDICT-1, its genotype-based registration trial of licaminlimab for dry eye disease.
The randomized, multicenter, double-blind, vehicle-controlled study enrolled 176 patients; two-thirds carry a specified TNFR1 genetic variant associated with greater clinical response in earlier Phase 2 trials. The primary endpoint is the change from baseline to day 29 in the overall score for severe ocular discomfort among patients with that variant. The same measure in the overall study population is a key secondary endpoint; efficacy and safety will also be assessed across that population.
Oculis expects topline results around year-end 2026. In an earlier Phase 2 symptom study, licaminlimab significantly reduced ocular discomfort versus vehicle at day 29, with treatment effects evident by day 14.
Oculis (OCS) completed randomization in PREDICT-1, its first registrational trial of Licaminlimab for dry eye disease, with 176 patients enrolled. Two-thirds carry a specific TNFR1 genetic variant previously associated with greater treatment response in Phase 2 trials. Oculis expects topline results around year-end 2026.
The multicenter, double-masked trial compares Licaminlimab with vehicle, the formulation without the active drug. Its primary endpoint measures change from baseline at Day 29 in global ocular discomfort severity among patients with the specified genotype. The same measure in all enrolled patients is a key secondary endpoint; safety is also being assessed. In a prior Phase 2 symptom trial, Licaminlimab produced a statistically significant reduction in ocular discomfort versus vehicle at Day 29, with onset observed as early as Day 14.
Oculis (OCS) published a notification concerning the vesting and settlement of previously granted restricted stock units, or RSUs. The notification relates to a member of its Executive Committee and Board of Directors. The attachment identifies Riad Sherif and an RSU vest dated October 5, 2026.
Oculis (OCS) will present Licaminlimab at Eyecelerator @ AAO 2026 on October 8 and sponsor Neuro-Ophthalmology Subspecialty Day on October 9.
CEO Riad Sherif will present the investigational topical treatment, which uses a genotype-based approach for TNFR1-mediated dry eye disease. Oculis expects the PREDICT-1 registrational symptoms trial, designed to support registration, to deliver topline results around year-end. The presentation is part of the Anterior segment showcase. The sponsored subspecialty day will take place at the American Academy of Ophthalmology Annual Meeting in New Orleans.
Oculis (OCS) has joined the National Multiple Sclerosis Society’s Campaign to End MS as its industry partner focusing on vision. The five-year campaign aims to accelerate research and improve access to care for people with multiple sclerosis.
Oculis has launched the PIONEER program, which includes two trials intended to support registration of Privosegtor for optic neuritis. Following positive FDA feedback before its investigational new drug application, Oculis expects to submit an application for treating acute MS relapses in Q4 2026. The company also plans an R&D Day in Q4 to update its pipeline and development programs.
Oculis (OCS) announced Lionel Carnot’s resignation from its Board of Directors, effective September 30, 2026, after serving since 2017. The company described his departure as a personal decision unrelated to disagreements over its operations, policies or practices; Carnot said he was stepping down to focus on other commitments.
Following the resignation, the Board will have eight members. Geraldine O’Keeffe will replace Carnot as Remuneration Committee chair, with Gregory Perry and Robert Warner as members. Under Swiss law, the Board vacancy can only be filled at a future annual or special general meeting. Oculis will begin identifying a successor.
Oculis (OCS) has published a notification of a managers’ transaction relating to the purchase of ordinary shares by a member of its Board of Directors.
The disclosed transaction concerns a board member identified in an attached document titled “notification-of-managers-transaction-lionel-carnot-14-september-2026,” which refers to activity dated 14 September 2026 and was published from Zug, Switzerland on 17 September 2026.
Oculis (Nasdaq: OCS) announced that the first patient has been treated in PIONEER-1, a registrational trial of Privosegtor for acute optic neuritis (ON). PIONEER-1, part of the broader PIONEER program, evaluates Privosegtor in ON patients with and without multiple sclerosis, using functional visual outcomes.
The primary endpoint is the proportion of patients achieving at least a 15-letter gain in visual acuity at Month 3; a key secondary endpoint is change in low-contrast visual acuity at Month 3. Patients will be followed to Month 12 for long-term safety. Trial design and planned analysis are covered by an FDA Special Protocol Assessment to support a future NDA in ON, subject to positive results. Privosegtor has Breakthrough Therapy, PRIME and Orphan Drug designations for ON and showed vision and neuroprotective benefits in the Phase 2 ACUITY trial. Oculis also plans an IND submission in Q4 2026 to study Privosegtor in acute multiple sclerosis relapses.
Oculis (NASDAQ: OCS) announced the publication of notifications related to the vesting and settlement of previously granted restricted stock units (RSUs) awarded to company directors. The notifications concern RSU vests dated August 13, 2026, for directors Anthony Rosenberg, Christina Ackermann, Arshad Khanani and Robert Warner.
Oculis (Nasdaq: OCS) signed an asset purchase agreement with Accure Therapeutics to acquire all worldwide development and commercial rights to Privosegtor (ACT-01), plus a separate transaction for ACT-02, an early-stage preclinical neurology candidate. The deal will terminate Oculis’ existing license with Accure, eliminating related milestone and royalty obligations for successful indications.
Total consideration includes a $3.8 million (CHF 3.1 million) cash payment at the first closing and up to 2,050,000 Oculis ordinary shares, split between locked-up upfront shares and milestone-based earnout shares. Oculis expects to assume low single-digit royalty obligations to academic licensors. Closing of ACT-01 is expected by February 28, 2027 and ACT-02 by March 31, 2027, subject to conditions. Privosegtor is in the PIONEER registrational program for optic neuropathies and holds FDA Breakthrough Therapy, EMA PRIME, and Orphan Drug designations in the U.S. and EU for optic neuritis.