OCS-01 - (DIAMOND-1)

August 6, 2026: Oculis Holding AG (NASDAQ: OCS) reported Q2 2026 updates across its late-stage pipeline. For Privosegtor, the registrational PIONEER-1 trial in optic neuritis remains on track with global site activation underway across the U.S., Europe, Australia, and Canada. Under an FDA Special Protocol Assessment, the primary endpoint is the proportion of patients achieving at least a 15-letter gain from baseline in low-contrast visual acuity at Month 3, with follow-up through Month 12 for safety/tolerability. Oculis also said FDA pre-IND feedback for Privosegtor in acute multiple sclerosis relapses was positive: no additional preclinical studies are required before IND submission, FDA supported the proposed development strategy and a 3-month primary endpoint, and the company plans an IND submission in Q4 2026.

For Licaminlimab, enrollment is progressing in the registrational PREDICT-1 genotype-based dry eye disease trial; all planned sites are activated and more than 45% of patients have been randomized. The study plans to enroll about 160 patients, with the primary endpoint change from baseline to Day 29 in global ocular discomfort severity score in TNFR1-genotype patients. Topline results are expected around year-end 2026.

For OCS-01, Oculis said it does not plan to pursue an FDA filing in DME following May DIAMOND topline results. Cash was $282.3 million at June 30, 2026, with runway into 2H 2029.