Oculis AG(US:OCS)2025-10-06 13:32Oculis 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]