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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) 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.
Oculis (NASDAQ: OCS) presented DME AWARE Delphi findings at ARVO 2026 highlighting unmet needs in diabetic macular edema (DME).
Experts prioritized non-invasive therapies and early intervention; consensus favored treating early-stage DME with an eye drop. Oculis expects topline DIAMOND Phase 3 results for OCS-01 in June 2026.
Oculis (Nasdaq: OCS) will present clinical and corporate updates at Eyecelerator and ARVO 2026, May 1–6, 2026. Presentations cover DIAMOND Phase 3 (OCS-01 eye drops) with topline results expected June 2026, DME AWARE Delphi Study findings on unmet needs in DME, and Phase 2 ACUITY post‑hoc OCT analyses for Privosegtor.
Sessions include a company update May 1, DME AWARE results May 4, and Privosegtor neuroprotective data May 6; recent regulatory designations and registrational programs are also highlighted.
Oculis (Nasdaq: OCS) published its invitation to the 2026 Annual General Meeting, to be held May 13, 2026 at Ochsen-Zug, Kolinplatz 11, CH-6300 Zug, Switzerland, with in-person attendance and a broadcast (no virtual participation).
Shareholders on Nasdaq US will receive physical proxy materials; Nasdaq Iceland shareholders may submit electronic voting instructions via the Lumi AGM platform. A shareholder information session with management is scheduled for May 11, 2026 in Reykjavík and via webcast; meeting materials and replays are available on the investor website.
Oculis (Nasdaq: OCS) completed the last patient visit in its two Phase 3 DIAMOND trials for OCS-01 eye drops in diabetic macular edema (total >800 patients). Topline results are expected in June 2026, with a potential NDA submission in Q4 2026.
Both 52-week, randomized, double-masked registrational trials follow positive Stage 1 findings showing visual acuity gains and rapid edema reduction; OCS-01 targets a U.S. market estimated at $3 billion.
Oculis (NASDAQ:OCS) announced the vesting and settlement of previously granted restricted stock units (RSUs) to a company director. The notification names Riad Sherif and cites an RSU vesting/settlement event dated 5 April 2026.
The disclosure is a routine insider transaction notice about equity compensation processing.
Oculis (Nasdaq: OCS) announced management will participate in investor conferences in April 2026, including a company presentation at the Needham Healthcare Conference on April 14, 9:30 AM ET, and one-on-one meetings at Van Lanschot Kempen Life Sciences Conference on April 15-16.
The company highlighted upcoming pivotal readouts: OCS-01 DIAMOND Phase 3 topline results due June 2026, Licaminlimab PREDICT-1 topline planned late 2026, and Privosegtor holding FDA Breakthrough and EMA PRIME designations for optic neuritis.