Oculis Holding AG (OCS) shares ended the last trading session 6.3% higher at $21.13. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 15.4% gain over the past four weeks.Earlier this week, the company announced that it has advanced its pipeline candidate, privosegtor, into a registrational program for neuro-ophthalmology indications after a positive meeting with the FDA. Oculis will begin three pivotal studies to su ...

Oculis Holding Update Summary Company Overview - **Company**: Oculis Holding AG - **Ticker**: NasdaqGM: OCS - **Industry**: Biopharmaceuticals focusing on neuro-ophthalmology - **Market Potential**: Over $25 billion in neuro-ophthalmology with specific indications for OCS-05 targeting acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION) [4][12][14] Key Developments - **FDA Interaction**: Successful meeting with the U.S. FDA allowing OCS-05 to advance into the registration phase for AON and NAION [5][6] - **Registration Trials**: - **Pioneer 1**: Planned to start in Q4 2025 for AON - **Pioneer 2**: Planned to start in the first half of 2026 for AON - **Pioneer 3**: Planned to start in mid-2026 for NAION [6][7][15] Clinical Trial Design - **Pioneer Trials**: - Pioneer 1 and 2 will mirror the successful Phase 2 Acuity trial with the same dose and patient population [6][9] - Primary endpoint: Change from baseline in Low Contrast Visual Acuity (LCVA) at month three [10][12] - Secondary endpoints include the proportion of 15-letter gainers at month three and change from baseline in LCVA at month six [10][12] Market Opportunity - **Acute Optic Neuritis (AON)**: - Estimated 30,000 cases per year in the U.S. - Potential market size of over $3 billion with treatment costs between $100,000 to $400,000 per year [12][13] - **Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)**: - Estimated 30,000 to 35,000 cases per year in the U.S. - Potential market size of over $4 billion [14][15] Financial Position - **Balance Sheet**: Strong with no debt and cash runway extending to the end of 2027 without utilizing loan facilities [5] Strategic Focus - **Pipeline**: Multiple pivotal milestones focusing on significant unmet medical needs in neuro-ophthalmology [15][16] - **Future Plans**: - Launching Predict, a Phase 3 trial in genotype-based development for dry eye [15] - Aiming to leverage data from AON trials for potential MS relapse indications [9][15] Regulatory and Clinical Insights - **Regulatory Pathway**: Full alignment with FDA on trial designs and IND submissions for both AON and NAION [5][6] - **Patient Population**: Trials will include both MS and non-MS patients, with a focus on all-comers for AON [9][12] - **Treatment Window**: Treatment should ideally start within 12 days of symptom onset, with an average of 9.5 days observed in previous studies [61] Community Engagement - **Feedback from Neuro-Ophthalmologists**: Positive reception and engagement from the medical community regarding OCS-05, with plans for strong presence at upcoming medical congresses [73][74] Conclusion - Oculis is positioned to be a leader in neuro-ophthalmology with a robust pipeline and significant market opportunities in AON and NAION, aiming to address critical unmet medical needs while maintaining a strong financial foundation [15][16][60]

Rethinking Ophthalmology Privosegtor FDA update Corporate Update 3 Oculis (Nasdaq / XICE: OCS) Three registrational programs in Neuro-Ophthalmic and Retina indications provide multi- billion-dollar market opportunities October 6th, 2025 Safe Harbor Statements Cautionary note on forward-looking statements These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," ...

Successful meeting with FDA enables advancement into pivotal development with Privosegtor in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Oculis will launch the PIONEER Program, which includes multiple global trials intended to support registrations in AON and NAION Company to host conference call and webcast at 8:30 AM ET today ZUG, Switzerland, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical com ...

ZUG, Switzerland, Sept. 26, 2025 (GLOBE NEWSWIRE) -- The attached notification relates to trades entered into by a PDMR of the Company pursuant to a 10b5-1 trading plan, in accordance with Rule 10b5-1(c)(1) of the Securities Exchange Act of 1934, as amended. Attachment pdmr-notification-r-sherif-sales-sep 2025 ...

Company Overview - Oculis Holding AG (OCS) shares increased by 6.7% to close at $17.73, following a period of 6.9% loss over the past four weeks, indicating a significant shift in investor sentiment [1][2]. Product Development - The rise in stock price is linked to growing optimism regarding three product candidates: OCS-01 for diabetic macular edema, OCS-05 for acute optic neuritis, and OCS-02 for personalized medicine in dry eye disease [2]. Financial Expectations - The company is projected to report a quarterly loss of $0.50 per share, reflecting a year-over-year increase of 9.1%. Expected revenues are $0.25 million, down 1.6% from the previous year [3]. - The consensus EPS estimate has been revised 7.3% higher in the last 30 days, suggesting potential price appreciation in the future [4]. Industry Context - Oculis Holding AG operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Incyte (INCY), experienced a 2.1% decline in its stock price [5]. - Incyte's EPS estimate has increased by 0.4% to $1.64, representing a year-over-year change of 53.3% [6].

ZUG, Switzerland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Privosegtor ACUITY Trial showed Improved LCVA and preservation of Ganglion Cells in Acute Optic Neuritis. Results from a Multicenter Randomized Placebo-Controlled Double-Masked Trial Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced the upcoming presentation of the positive Phase 2 ACUITY tria ...

Oculis Holding (NasdaqGM:OCS) 2025 Conference September 09, 2025 03:45 PM ET Company ParticipantsRiad Sherif - CEO[Senior Analyst]I'm one of the senior analysts covering biotech at Baird, and I'm pleased to have with us the team from Oculis, including Riad Sherif, CEO.Riad SherifThank you. Thank you for inviting us.[Senior Analyst]Maybe if you could kick us off, Riad, with just a brief company overview of Oculis for those that are less familiar.Riad SherifYes. Oculis is a biopharma company focusing on ophth ...

Summary of Oculis Holding FY Conference Call Company Overview - **Company**: Oculis Holding AG - **Ticker**: NasdaqGM: OCS - **Date of Conference**: September 08, 2025 Key Clinical Programs 1. **OCS-01 for Diabetic Macular Edema (DME)** - First eye drop treatment for DME, currently in Phase 3 with enrollment completed - Expected readout in Q2 2026 - Market potential in the U.S. is estimated at $3 billion, targeting a patient pool twice the size of current treatments [3][4] - Primary endpoint: mean change of Best Corrected Visual Acuity (BCVA) compared to placebo [10] - Secondary endpoint: percentage of patients gaining 15 letters in BCVA [10] - Positioned as a first-line treatment for DME [13] 2. **OCS-02 (Licaminlimab) for Dry Eye Disease** - Utilizing a genotype-based approach to identify patients likely to respond to treatment - Current market for dry eye is underserved, with a low renewal rate of first prescriptions at 14% [6][7] - Expected initiation of trials this year, with readout in the second half of next year [40] 3. **OCS-05 (Privosergtor) for Acute Optic Neuritis (AON)** - Phase 2 data showed significant functional improvement, with an 18-letter difference in vision [5] - Plans to consult with the FDA regarding registration for AON and initiate new programs for NAION and MS relapse [6][21] - AON will be the lead indication for Phase 3 trials [23] Market Position and Competitive Landscape - Oculis aims to address unmet medical needs in DME, with over 60% of diagnosed patients currently untreated [11] - OCS-01 shows comparable or superior efficacy to existing treatments like Lucentis and Ozurdex [12] - The company is focused on execution and has clear regulatory support from the FDA [18] Financial Overview - Current cash runway extends to early 2028, financing DME and dry eye trials until NDA submission [42] - The company is exploring potential licensing or co-development opportunities but cannot disclose specifics [41] Upcoming Catalysts - Regulatory clarifications for Privosergtor in AON and IND submissions for NAION and MS relapse [43] - Phase 3 readout for DME expected in the first half of next year and for dry eye in the second half [43] Additional Insights - The company emphasizes the importance of execution in clinical trials, acknowledging inherent risks [18] - The genotype-based approach in ophthalmology is a novel strategy, potentially leading to more efficient trials [37][38] This summary encapsulates the critical points discussed during the conference call, highlighting Oculis Holding's strategic focus on its clinical programs, market positioning, financial health, and upcoming milestones.

Core Insights - Oculis Holding AG announced the winner of the Ramin Tadayoni Award 2025, recognizing contributions in retinal research [1][2] - The award honors Dr. Prithvi Ramtohul for his significant work in retinal imaging and diseases [3][4] - Oculis is committed to advancing retinal research and honoring the legacy of Professor Ramin Tadayoni [4] Company Overview - Oculis is a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs [6] - The company has a late-stage clinical pipeline that includes three core product candidates: OCS-01 for diabetic macular edema, Privosegtor (OCS-05) for acute optic neuritis, and Licaminlimab (OCS-02) for dry eye disease [6] - Oculis is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team [6]