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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) announced the publication of a notification related to a managers' transaction on June 9, 2026 in Zug, Switzerland.
The attached notification concerns the purchase of ordinary shares by a member of the company’s Executive Committee and Board of Directors.
Oculis (Nasdaq: OCS) randomized the first patient in PREDICT-1, a genotype-based registrational trial of Licaminlimab for dry eye disease. The FDA-aligned study targets patients with a specific TNFR1 genotype to evaluate symptom relief and safety versus vehicle.
PREDICT-1 plans to enroll ~160 patients, with about two-thirds carrying the target genotype; ~70% of sites are activated. The trial aims to deliver a first-in-class precision medicine approach in a U.S. market where only ~13% of patients experience sustained relief.
Oculis (Nasdaq: OCS) will participate in a fireside chat at the 47th Annual Goldman Sachs Global Healthcare Conference on June 9 at 4:00 p.m. ET in Miami, FL.
Management will discuss late-stage assets Privosegtor and Licaminlimab, key trials, funding and upcoming pivotal readouts.
Oculis (NASDAQ:OCS) reported a notification of transactions by a person discharging managerial responsibilities. The notice concerns the vesting and settlement of RSUs previously granted to a company director on May 29, 2026.
Oculis (Nasdaq: OCS) reported topline Phase 3 DIAMOND-1 and DIAMOND-2 results for OCS-01 in diabetic macular edema. The primary BCVA endpoint and key ≥15-letter gain endpoint at Week 52 were not met.
Retinal thickness was substantially reduced vs vehicle, safety was consistent with prior trials, and no FDA filing in DME is planned. Oculis will prioritize its Privosegtor PIONEER optic neuropathy program and Licaminlimab PREDICT-1 dry eye trial, supported by $278 million in cash and runway into 2H 2029.
Oculis (OCS) announced a notification related to transactions by a person discharging managerial responsibilities. The attached document concerns the vesting and settlement of RSUs previously granted to a company director, identified as Arshad Khanani, with a vesting date of May 25, 2026.
Oculis (OCS) reported notifications of transactions by persons discharging managerial responsibilities. These relate to vesting and settlement of RSUs previously granted to directors, annual equity incentive awards to directors, and a one-time equity grant to a new director upon his election to the board.
Oculis (Nasdaq: OCS) reported that shareholders approved all items at the 2026 Annual General Meeting, including the election of Gregory D. Perry to the Board of Directors and key capital measures.
For 2025, the Company recorded a standalone loss of CHF 33.67 million, with an accumulated loss of CHF 80.25 million carried forward.
Shareholders approved a capital band of 31,020,888 shares and a conditional share capital of 12,677,700 shares for employee-related purposes. Following recent share issuances, registered shares will rise to 67,792,176, including 5,750,400 new treasury shares, resulting in treasury holdings of 9.15% of registered shares.
Oculis (Nasdaq: OCS) reported Q1 2026 financial results and key pipeline updates. Last patient last visit was completed in both Phase 3 DIAMOND trials of OCS-01 for DME, with topline data expected June 2026 and a potential NDA filing in Q4 2026.
Licaminlimab PREDICT-1 in dry eye disease is actively recruiting, with topline results expected around year-end. Privosegtor received EMA PRIME designation and an FDA Special Protocol Assessment for the PIONEER-1 registrational trial in optic neuritis. Cash, cash equivalents and short-term investments were $277.6 million, providing runway into 2H 2029. Q1 net loss was CHF 28.9 million (CHF 0.49 per share).
Oculis (Nasdaq: OCS) received a Special Protocol Assessment (SPA) from the U.S. FDA for PIONEER-1, the first registrational Phase 3 trial of Privosegtor in optic neuritis (ON). The SPA affirms trial design and analysis as adequate to support a potential NDA submission, subject to positive results and FDA review.
The PIONEER-1 primary endpoint is the proportion of patients gaining ≥15 letters in low-contrast visual acuity at Month 3; patients will be followed 12 months for safety and tolerability. Privosegtor previously showed vision improvements and favorable safety in Phase 2 ACUITY and holds FDA Breakthrough and EMA PRIME designations.