Ocular Therapeutix (OCUL) 2025 Conference May 20, 2025 02:35 PM ET Speaker0 Capital Markets and it is our great privilege to have Ocular Therapeutics joining us for a fireside chat. Representing the company we have Praveen Dugal, Executive Chair, President, and CEO. Praveen, thanks so much for joining us. How are you doing today? Speaker1 Great, Lisa, and thank you. Thank you for having us on this great conference. An honor to be here, and thank you for the invitation. Speaker0 Excellent. Well, Praveen, jus ...

Summary of Ocular Therapeutix (OCUL) Conference Call Company Overview - **Company**: Ocular Therapeutix (OCUL) - **Product**: ExPaxly, a treatment for wet age-related macular degeneration (AMD) Key Industry Insights - **Regulatory Environment**: The FDA remains consistent and collaborative, with no recent changes affecting timelines or processes [3][4][5] - **Market Context**: The wet AMD market is crowded with existing treatments, including recent generic launches [6] Core Product Differentiation - **ExPaxly's Unique Selling Proposition**: - Aims to address the high dropout rate of 40% in current treatments, which leads to significant patient blindness [11][52] - Offers less frequent dosing, potentially every six to twelve months, compared to current treatments requiring monthly or bi-monthly visits [13][58] - Focuses on sustainability and better long-term outcomes by providing a constant drug delivery, reducing the risk of fibrosis and atrophy [19][18] Clinical Trials - **Current Trials**: - **SOUL-one**: A superiority trial designed to select patients with high VEGF receptor levels [21][25] - **SOLAR**: A non-inferiority trial aimed at ensuring stability in patient responses [21][26] - **Trial Design**: - Both trials are complementary, allowing for a comprehensive understanding of ExPaxly's efficacy and safety [22][28] - The trials have been designed to maximize patient retention and minimize dropout rates [29][44] Regulatory Strategy - **SPA (Special Protocol Assessment)**: The company has maintained its SPA with the FDA, allowing for an extended study period to gather more safety data [44][48] - **Amendments**: Recent amendments to the trials have reduced the number of patients needed for SOLAR, expediting the process while maintaining compliance with FDA guidelines [45][47] Market Potential and Economic Impact - **Patient Retention**: A reduction in dropout rates could lead to significant cost savings for the healthcare system, with estimates of preventing a quarter million patients from going blind [53][60] - **Future Indications**: Plans to expand into non-proliferative diabetic retinopathy and diabetic macular edema, leveraging the efficacy of ExPaxly in these conditions [60][62] Conclusion - **Company's Focus**: Ocular Therapeutix is laser-focused on the success of its clinical trials for ExPaxly, with a strong emphasis on maximizing shareholder value and ensuring a positive impact on patient care [61][64]