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  "documentTitle": "Oculis | Investor Conference Presentation Deck | 39 slides",
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  "authorName": "Oculis",
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  "presentationDate": "2023-06-01 00:00:00",
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      "text": "Stage 1 (N = 148)\n6 weeks\nOCS-01 6x/day\nOCS-01 3x/day\nVehicle 6x/day\nVehicle 3x/day\nStage 2 (N = 350 - 450 per trial; 1:1 Randomization)\n52 weeks\nOCS-01: 6x/day weeks 1 - 6; 3x/day weeks 7 - 52\nVehicle: 6x/day weeks 1 - 6; 3x/day weeks 7 - 52\nEnd of Trial",
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      "text": "Stage 2: Two Phase 3's to support NDA filing for DME\n1º endpoint: BCVA at wk 52\nKey 2º endpoint: ≥ 3-line (15 letters) at wk 52\n2º endpoint: CST at wk 52",
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      "text": "Stage 1: Assess if loading dose optimizes efficacy\n1º endpoint: Change in BCVA ETDRS letter score at wk 6\n2º endpoint: % with a ≥ 3-line (15 letters) gain in BCVA at wk 6/12\n2º endpoint: Change in CST as measured by SD-OCT(1) at wk 6/12\n2º endpoint: Change in BCVA at wk 12",
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      "text": "Key Enrollment Criteria\nAge 18-85 years\nDiabetes mellitus 1 and 2\nETDRS BCVA letter score: 24-65\nRetinal thickness (CST) ≥ 310 μm\nAnti-VEGF and corticosteroid naïve or agree to washout",
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      "text": "Washout (if needed): 3 - 6 months depending on prior treatment",
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      "text": "(1) Spectral Domain Optical Coherence Tomography",
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      "text": "OCS-01 | Phase 3 Program in DME Patients",
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