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Oculis Holding AG (Nasdaq: OCS) is a leading global biopharmaceutical company dedicated to saving sight and enhancing eye care. Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is at the forefront of developing innovative treatments for serious eye diseases. The company's pipeline includes several promising candidates:
- OCS-01: A topical eye drop for diabetic macular edema (DME) and post-cataract surgery inflammation and pain. OCS-01 has shown compelling Phase 3 data, making it a potential new standard of care for these conditions.
- OCS-02: A topical biologic anti-TNF伪 eye drop for dry eye disease (DED) and non-infectious anterior uveitis. The OCS-02 RELIEF trial is in Phase 2b, with results eagerly anticipated.
- OCS-05: A neuroprotective candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma and diabetic retinopathy. The ACUITY trial is set to provide critical data by the end of the year.
Oculis recently announced its fourth-quarter and full-year 2023 financial results, highlighted by positive Phase 3 data for OCS-01 and the commencement of three clinical trials, including OCS-02's RELIEF trial. The company is on track for a catalyst-rich 2024 with significant upcoming milestones, including readouts from the RELIEF trial in Q2 and the OPTIMIZE-2 and ACUITY trials in Q4. These milestones are crucial for Oculis' plan to submit its first New Drug Application (NDA).
Under the leadership of CEO Riad Sherif, M.D., Oculis has achieved remarkable progress and continues to advance its diversified pipeline. The company is backed by leading international healthcare investors and boasts a seasoned management team with a strong track record of success.
Financially, Oculis has reported significant strides, supported by both new and existing investors. The company has dual listings on Nasdaq in the U.S. and Iceland, reflecting its robust financial health and market confidence.
For more information, please visit . For investor and media inquiries, contact Ms. Sylvia Cheung, CFO at sylvia.cheung@oculis.com or Corey Davis, Ph.D. at LifeSci Advisors at cdavis@lifesciadvisors.com.
Oculis announced positive topline results from its Phase 2 ACUITY trial for OCS-05, a potential first-in-class neuroprotective therapy for acute optic neuritis. The trial met its primary safety endpoint and achieved statistical significance on key efficacy endpoints.
The randomized, double-blind study evaluated 33 patients receiving OCS-05 (2mg/kg/day or 3mg/kg/day) administered intravenously for five days. Key results include:
- 43% improvement in GCIPL thickness at 3 months for OCS-05 (3mg/kg/day)
- 28-30% improvement in RNFL thickness at 3-6 months
- Approximately 18 letters improvement in visual function at 3 months
The treatment showed a favorable safety profile with no serious adverse events or discontinuations. The FDA has granted orphan drug designation and cleared the IND application, enabling U.S. clinical development. The company reports approximately $105-110 million in cash and equivalents.
Oculis (Nasdaq: OCS) announced positive topline results from its Phase 2 ACUITY trial for OCS-05, a neuroprotective therapy candidate for acute optic neuritis. The trial met its primary safety endpoint and achieved statistical significance on key efficacy endpoints. The study demonstrated a 43% improvement in GCIPL thickness and 28% improvement in RNFL thickness with OCS-05 (3mg/kg/day) plus steroid versus placebo at 3 months.
The trial involved 36 randomized patients, with 33 included in the modified intent-to-treat analysis. Visual function improvements showed approximately 18 letters improvement at month 3 and 15 letters at month 6. No drug-related serious adverse events were reported, with headache and acne (10.5% each) being the most common side effects.
OCS-05 has received orphan drug designation from both FDA and EMA, and its IND application has been cleared by the FDA. The company reports approximately $105-110 million in cash and equivalents entering 2025.
On January 4, 2025, Oculis Holding AG announced a significant change in its voting rights structure. The change occurred due to Brunnur vaxtarsj贸冒ur slhf distributing its shares in Oculis to its own shareholders. This redistribution of shares represents a major shift in the company's ownership structure.
Oculis has published notifications regarding transactions by individuals with managerial responsibilities. The notifications pertain to the vesting and settlement of Restricted Stock Units (RSUs) previously granted to the company's directors.
The attached documents detail the transactions for two directors:
- Anthony Rosenberg - December 2024
- Arshad Khanani - December 2024
Oculis has announced the vesting of earnout shares and the removal of restrictions on these ordinary shares.
The notifications involve key managerial figures, including Anthony Rosenberg, Riad Sherif, Sylvia Cheung, and Pall Johanesson. Each notification details specific transactions related to these individuals.
The vesting of these shares signifies a notable event for the company and its stakeholders, potentially impacting stock performance due to changes in share availability and managerial ownership.
Oculis has announced a one-time equity incentive award issued to a director for his independent services as a consultant. The notification of this managerial transaction involves Arshad Khanani and was published in November 2024.
Oculis Holding AG (Nasdaq: OCS), a global biopharmaceutical company focused on eye care and sight preservation, has announced its participation in the Stifel 2024 Healthcare Conference. The event will take place on November 18-19, 2024, at the Lotte New York Palace Hotel. Sylvia Cheung, Chief Financial Officer, will participate in a fireside chat on November 18 at 3:35 pm ET. The presentation will be available via live webcast, and the company will conduct one-on-one meetings with investors during the conference. Access to the fireside chat will be provided through Oculis' website under the Investors & Media section.
Oculis Holding AG (Nasdaq: OCS) reported Q3 2024 financial results with cash position of $125.0 million, providing runway into 2H 2026. The company achieved significant enrollment progress in its DIAMOND Phase 3 trials, with ~70% enrolled in DIAMOND-1 and ~40% in DIAMOND-2. Research and development expenses increased to $15.0 million, up from $10.0 million in Q3 2023. The company reported a Q3 net loss of $23.3 million. Key upcoming milestones include OCS-05 Phase 2 ACUITY trial topline results expected in December 2024 and planned NDA submission readiness for OCS-01 in Q1 2025.
Oculis Holding AG (Nasdaq: OCS) announces accelerated patient enrollment for its Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME). The DIAMOND program has made substantial progress, with ~70% of patients enrolled in DIAMOND-1 and ~40% in DIAMOND-2. The company has also expanded its DIAMOND program committees with globally renowned retina experts.
The DIAMOND trials are evaluating the efficacy and safety of OCS-01 eye drops in DME patients. If approved, OCS-01 could potentially transform the treatment paradigm as the first topical eye drop to treat DME. Results from Stage 1 of the program showed significant improvements in visual acuity and clinically meaningful reduction in macular edema for patients treated with OCS-01.
Oculis Holding AG (Nasdaq: OCS) announces accelerated patient enrollment for both Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME). The DIAMOND-1 trial has enrolled ~70% of patients, while DIAMOND-2 has enrolled ~40%. The company has also expanded its DIAMOND program committees with globally renowned retina experts.
The DIAMOND program consists of two Phase 3, double-masked, randomized, multi-center trials evaluating the efficacy and safety of OCS-01 eye drops in DME patients. If approved, OCS-01 has the potential to be the first topical eye drop to treat DME, potentially transforming the treatment paradigm.
Dr. Arshad M. Khanani, DIAMOND Program Steering Committee Chairperson, highlighted promising results from Stage 1 of the DIAMOND Phase 3 program, showing significant improvements in visual acuity and clinically meaningful reduction in macular edema for patients treated with OCS-01.
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