Ocular Therapeutix (OCUL) investor relations material

Company and product overview

• Focuses on a tyrosine kinase inhibitor (TKI) delivered via a proprietary hydrogel platform targeting VEGF for diseases like wet macular degeneration and diabetic retinopathy.

• Aims to address sustainability and long-term vision loss issues in current treatments by improving patient adherence and outcomes.

• Seeks to provide a more durable therapy, reducing the need for frequent injections and improving long-term vision retention.

Regulatory and clinical development updates

• Plans to file a BLA/NDA for AXPAXLI by the end of the year, targeting market entry in 2027, following positive alignment with the FDA.

• SOL-1 phase III study met all FDA evidentiary standards for a single trial submission, including masking, powering, and safety data from over 300 patients.

• Safety data from the ongoing SOL-R study will be handled by a third party to maintain study integrity, with FDA alignment on this process.

• SOL-1 demonstrated superiority over EYLEA with a statistically significant reduction in vision loss and strong safety and durability data.

• SOL-R is designed as a non-inferiority study for OUS approvals, with a rigorous patient selection process to ensure stable participants.

Commercial strategy and market positioning

• Expects rapid adoption due to increased durability, ease of integration into existing workflows, and favorable pricing.

• Commercial team is experienced, with leadership from a successful EYLEA launch, and manufacturing scale-up is complete for anticipated demand.

• Positioned to compete effectively in a concentrated retina market due to strong relationships and a specialized sales force.