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Oculis Holding (OCS) FY Conference Transcript
2025-08-13 12:00
Summary of Oculus Conference Call Company Overview - Oculus is a global biopharma company listed on Nasdaq, focusing on innovative ophthalmology and neuro-ophthalmology candidates targeting significant market opportunities [3][4] Core Assets 1. **OCS-01 (OptiReach)**: A high concentration dexamethasone eye drop for diabetic macular edema (DME), currently in phase three with readout expected in 2026 [3][4] 2. **Privelceptor (OCS-05)**: A first-in-class neuroprotective candidate for acute optic neuritis, currently in development [4][13] 3. **Lickamenimab (OCS-02)**: A novel topical anti-TNF candidate for dry eye disease, starting phase two/three trials in the second half of the year [4][28] Market Insights - **Diabetic Macular Edema (DME)**: - Affects 37 million patients globally, expected to grow to over 50 million by 2045 [6] - Current treatments are invasive, leading to low patient compliance; 56% of diagnosed patients are untreated [6][7] - The U.S. addressable patient population for OCS-01 is estimated at 1.3 million, with a market value of approximately $3 billion [12] - **Acute Optic Neuritis (AON)**: - No approved treatments currently exist; estimated 65,000 patients in the U.S. [15] - High unmet need for neuroprotective therapies [16][24] - **Multiple Sclerosis (MS)**: - Affects approximately 2.8 million worldwide, with a market valued above $20 billion [24] - Oculus aims to address relapses and neuroprotection during acute periods [25] - **Dry Eye Disease**: - A large and unsatisfied market; only 13% of patients experience lasting relief after 12 months [30] - Lickamenimab shows five times better efficacy in signs and seven times better in symptoms for patients with the TNF-R1 genotype [31][32] Clinical Trial Results - **OCS-01**: - Achieved 7.6 letter gains in best corrected visual acuity (BCVA) at week 12 [11] - 27.4% of patients had a 15-letter gain by week 12 [11] - Well tolerated with no unexpected adverse events [11] - **Privelceptor**: - Achieved primary safety endpoint and significant improvements in visual function and neuroprotection in the ACQUITY trial [20][21] - 43% improvement in GCIPL thickness and 30% in RNFL thickness at month six [20][21] - **Lickamenimab**: - Demonstrated rapid treatment effects in both signs and symptoms of dry eye disease [31] - Well tolerated with low incidence of adverse events [34] Future Plans - Anticipate top-line results from OCS-01 phase three program in 2026, with NDA filing in the second half of 2026 [41] - Plans to initiate phase two/three trials for AON and dry eye disease in upcoming quarters [41] - Strong balance sheet to support ongoing development activities [41] Conclusion - Oculus is positioned with a robust portfolio of differentiated products addressing significant unmet needs in ophthalmology and neuro-ophthalmology [40] - Upcoming catalysts across multiple assets and indications are expected to drive growth and shareholder value [40][41]