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    Colleen Hanley • Baird

    Colleen Hanley's questions to Ocular Therapeutix Inc (OCUL) leadership

    Colleen Hanley's questions to Ocular Therapeutix Inc (OCUL) leadership • Q4 2024

    Question

    Colleen Hanley asked if the redosing in SOL-1 is solely for FDA safety requirements or if it includes an efficacy component. She also inquired about the reason for changing the SOL-R primary endpoint from 48 weeks to 56 weeks and requested an update on SOL-R recruitment timelines.

    Answer

    President and CEO Dr. Pravin Dugel explained the SOL-1 redosing is primarily for FDA safety requirements but also provides valuable data on 12-month durability, which could support label flexibility, while the primary endpoint at 9 months remains unchanged. He clarified the SOL-R endpoint shifted to 56 weeks after the FDA indicated a preference for an endpoint at 52 weeks or later, a change from the initial 'at risk' proposal of 48 weeks. He noted SOL-R recruitment was strong but it was too early for a specific timeline update.

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    Colleen Hanley's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2024

    Question

    Colleen Hanley asked if Ocular intends to pursue a Special Protocol Assessment (SPA) for the SOL-R study following the positive FDA feedback. She also questioned if any modifications are planned for the SOL-R trial design and sought confirmation on the FDA's view of the high-dose Eylea comparator arm's role.

    Answer

    Dr. Pravin Dugel, President and CEO, explained that the company received a written response to its Type C meeting request and has not yet decided whether to pursue a SPA for SOL-R, as the primary goal is speed to market. He stated that no significant changes to the SOL-R design are anticipated, as the FDA found it acceptable for registration. He reiterated that the comparator arm is for masking purposes only and not for statistical analysis, which is in line with FDA requirements.

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