Oculis (OCS) Study result summary

Phase III Study Design and Patient Population

• Two global, multicenter, randomized Phase III trials (DIAMOND-1 and DIAMOND-2) evaluated OCS-01 versus vehicle in over 800 diabetic macular edema (DME) patients aged 18–85 with confirmed DME and specific visual and retinal thickness criteria.

• The induction phase lasted 6 weeks (6x/day dosing), followed by a 46-week maintenance phase (3x/day dosing).

• Over 80% of patients completed the 52-week study, with balanced baseline demographics and high compliance.

• No material differences were observed between phakic and pseudophakic patients, and trial execution quality was confirmed.

• Over 800 patients were enrolled across 119 sites in the US and other countries.

Efficacy Results

• Both DIAMOND-1 and DIAMOND-2 trials did not meet the primary endpoint of mean change in best corrected visual acuity (BCVA) at week 52 (DIAMOND-1: 1.2 vs 5.1 letters; DIAMOND-2: 4.6 vs 5.2 letters for OCS-01 vs vehicle).

• The key secondary endpoint (≥15-letter gain in BCVA) was not met (DIAMOND-1: 16.1% vs 23.4%; DIAMOND-2: 19.1% vs 22.6% for OCS-01 vs vehicle).

• OCS-01 showed rapid, substantial, and sustained reduction in central subfield thickness (CST) compared to vehicle at week 52 (DIAMOND-1: -51.8 μm vs -31.7 μm; DIAMOND-2: -64.3 μm vs -18.8 μm).

• High placebo response in DME trials was unexpected and higher than historical controls, with no clear explanation from available data.

• No issues identified with trial conduct, compliance, or execution; all KPIs for dropout, cataract, and IOP were met.

Safety Findings

• OCS-01 was well tolerated with no unexpected adverse events; elevated intraocular pressure (IOP) and cataract rates were consistent with chronic steroid use.

• Overall safety profile aligned with previous studies.