Ocular Therapeutix (OCUL) Piper Sandler 37th Annual Healthcare Conference summary

Strategic focus and clinical development

• Two phase III studies, SOL-1 and SOL-R, are underway targeting retinal diseases, with SOL-1 data expected in Q1 2026 and SOL-R in H1 2027.

• Both trials are designed to address sustainability and long-term outcomes in retinal disease treatment, aiming for better patient adherence and improved vision preservation.

• SOL-1 is structured to achieve a superiority label, while SOL-R focuses on clinical relevance and includes a high-dose EYLEA arm for commercial leverage.

• The studies are aligned with FDA guidance, using Special Protocol Assessments (SPAs) to minimize regulatory risk.

• Patient selection is highly strategic, with bespoke de-risking for each trial to ensure robust and reliable results.

Target product profile and market adoption

• The target profile centers on a triad: superiority label, large market size, and seamless adoptability for clinicians.

• Superiority label enables clinicians to choose the drug from day one, bypassing step therapy and maximizing reimbursement.

• No workflow changes or new equipment are required, facilitating rapid adoption.

• Durability is key, with the goal of a product lasting 9–10 months to align with six-month patient visits.

• The approach aims to address current limitations of anti-VEGF therapies, which lack reliable, long-lasting treatment intervals.

Competitive positioning and regulatory strategy

• Achieving a superiority label versus anti-VEGF agents is positioned as a unique and highly valuable differentiator.

• Long-term data from the SOL-X extension study will support the case for early and sustained use.

• Intellectual property has been extended to 2044, creating a strong competitive moat.

• The masking arm in SOL-R uses high-dose EYLEA, providing valuable comparative data and meeting FDA requirements.

• Patient selection and trial design are optimized to minimize variability and maximize the likelihood of regulatory and commercial success.