Summary of Oculus Fireside Chat Company Overview - **Company**: Oculus - **Industry**: Ophthalmology and Neuro-Ophthalmology - **Key Focus**: Development of a diversified and unique ophthalmology pipeline addressing unmet needs in ophthalmology and neuro-ophthalmology diseases with novel assets [1][2] Core Assets 1. **OCS O1**: - Based on OptiReach technology, designed for diabetic macular edema (DME) - Targets early intervention and non-responders among the 1.8 million diagnosed patients, with only 500,000 currently treated [4][34] - Aims to address the 1.3 million patients not receiving adequate treatment [4][36] 2. **OCS O2 (Lickamimab)**: - First precision medicine for dry eye disease, targeting patients with TNF R1 genotype - Approximately 10 million patients suffer from moderate to severe dry eye, with 20% having the TNF R1 gene, showing significantly better responses [5][44] 3. **OCS O5 (Privel Sector)**: - A novel neuroprotective treatment for acute optic neuritis, an orphan disease with no current neuroprotective treatments available - Positive data from Phase 2 ACUITY trial showing biological, anatomical, and functional efficacy [6][9][11] Market Dynamics - **DME Market**: - Current treatments are invasive (anti-VEGF and steroid implants), leading to low compliance; 60% of diagnosed patients are untreated [33] - OCS O1 aims to fill the treatment void for early-stage patients and provide a non-invasive option for those already treated [34][36] - **Acute Optic Neuritis**: - Estimated 65,000 patients in the US and Europe, with no approved products currently available [20] - OCS O5 is positioned to improve low contrast visual acuity (LCVA) and preserve neuronal health [20][24] Clinical Development and Regulatory Pathways - **OCS O5**: - Moving towards registrational studies based on positive Phase 2 results, with FDA interactions planned for the second half of the year [27][28] - **OCS O1**: - Phase 3 trial ongoing with over 800 patients, expecting results in Q2 of next year [39][41] - **Dry Eye Program**: - Phase 3 study design approved by the FDA, focusing on TNF R1 positive patients with a primary endpoint of global ocular discomfort score [42][44] Upcoming Catalysts - Regulatory interactions with the FDA for OCS O5 across three indications (acute optic neuritis, MS relapses, NAION) [47] - Top-line results from the DME trial expected in Q2 of next year [48] - Dry eye study results anticipated in the second half of next year [48] Additional Insights - The company emphasizes the importance of non-invasive treatments in improving patient compliance and outcomes in ophthalmology [35][41] - The potential for OCS O5 to expand into other indications beyond acute optic neuritis, such as glaucoma, is acknowledged [18][24]