Ocular Therapeutix (OCUL) investor relations material

Company overview and therapeutic focus

• Focuses on wet macular degeneration and diabetic retinopathy, targeting the VEGF receptor for both indications.

• Addresses unmet needs in sustainability and long-term outcomes due to limitations of current pulsatile injection therapies.

• Utilizes a proprietary hydrogel format to deliver a tyrosine kinase inhibitor for improved disease management.

Clinical trial results and regulatory strategy

• SOL-1 pivotal study demonstrated superiority over anti-VEGF with a robust p-value (0.0006), meeting its primary endpoint.

• SOL-1 showed 75% of patients were rescue-free at 9 months and 66% at 12 months after a single injection.

• Disease control by OCT was unprecedented, with most patients within 30 microns of fluctuation at month nine.

• Plans to file for approval based on SOL-1 alone, with ongoing formal discussions and alignment with the FDA.

• Regulatory environment is shifting toward innovation and faster patient access, with FDA support for trial modifications.

Market positioning and adoption

• Durability and sustainability are highly valued; historical data show even incremental improvements drive adoption.

• Anticipates broad adoption due to ease of integration into current workflows and strong patient/physician demand for less frequent dosing.

• Expects the drug to perform better in real-world settings than in phase III trials due to the challenging patient population in SOL-1.

• Commercial infrastructure is in place, with experienced leadership and ongoing scale-up in manufacturing and automation.