Ocular Therapeutix (OCUL) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Regulatory validation and trial design

• FDA accepted the phase III SOLAR trial as a registration-enabling study, confirming in writing that SOLAR and SOL-1 together are sufficient for approval, with no additional studies required.

• The FDA explicitly stated that sham controls are not recommended and do not constitute proper masking, validating the trial design approach.

• SOL-1 is a superiority study, while SOLAR is a non-inferiority study, both designed to minimize patient variability and maximize the chance of success.

• Both trials randomize patients only after a loading phase, ensuring a de-risked patient population.

• The FDA prefers two different study designs reaching the same conclusion, which is the strategy being pursued.

Enrollment progress and timelines

• SOL-1 enrollment is progressing at a historic pace, with 151 patients enrolled just eight weeks after team assembly.

• Enrollment for SOL-1 is expected to complete by the end of Q1 2025, with potential for earlier completion.

• SOLAR enrollment benefits from the design, as patients who do not qualify for SOL-1 can enter SOLAR, and the screen failure rate is lower than expected.

• The majority of SOLAR patients are expected to come from outside SOL-1 due to the low screen failure rate.

• The company controls the switch between SOL-1 and SOLAR enrollment to optimize recruitment.

Competitive positioning and market strategy

• Success in both trials could result in the only drug with a superiority label and flexible dosing every six to nine months.

• SOLAR includes a high-dose Eylea arm for masking, not statistical analysis, and the company is confident in its results against competitors.

• The drug aims to reduce patient dropout rates, potentially expanding the market significantly.

• Sustained suppression is expected to improve long-term outcomes and reduce vision-threatening complications.

• The product is designed for easy adoption without workflow changes for physicians.