Oculis (OCS) investor relations material

Study design and execution

• Two global, multicenter, randomized Phase III trials (DIAMOND-1 and DIAMOND-2) evaluated OCS-01 in diabetic macular edema, enrolling over 800 patients across 119 sites with well-balanced baseline characteristics.

• The primary endpoint was change in BCVA ETDRS letter score at week 52, with key secondary endpoints including ≥15 letter gain in BCVA and CST change from baseline.

• Over 80% of patients completed the 52-week daily treatment, indicating strong protocol adherence and execution.

• Compliance, dropout rates, and monitoring of cataract and IOP were within expected parameters, with no material differences between phakic and pseudophakic groups.

• No clinical trial conduct issues or execution problems were identified across sites.

Efficacy and safety results

• Both DIAMOND-1 and DIAMOND-2 failed to meet their primary and key secondary endpoints at week 52, showing no significant functional improvement in BCVA.

• OCS-01 demonstrated a rapid, substantial, and sustained reduction in retinal thickness, but this did not translate into functional vision gains.

• OCS-01 was well-tolerated with no unexpected adverse events, and the safety profile was consistent with previous trials; elevated IOP and cataract rates were higher as expected for steroid use.

• No meaningful efficacy differences were observed between phakic and pseudophakic patients.

• No licensing fees or financial obligations are triggered by the outcome; routine site closeout costs are expected in Q2 and Q3.

Strategic implications and future plans

• No FDA regulatory filing will be pursued for OCS-01 in DME based on these results.

• Focus will shift to advancing late-stage assets, particularly the Privosegtor platform (PIONEER program for optic neuropathies) and licaminlimab (PREDICT-1 trial for dry eye disease).

• PREDICT-1 is a registrational trial targeting TNFR1-positive dry eye patients, with updates expected around year-end or early next year; site activation and patient screening are ongoing.

• PIONEER-1 for optic neuritis is aligned with FDA under SPA, with over 70 sites in various stages of activation and first patient treatment expected soon.

• Financial position remains strong with $278 million in cash and equivalents as of March 31, 2026, providing runway into the second half of 2029, assuming no major further expenses for OCS-01 beyond wind-down activities.