Oculis Starts PIONEER-1 Trial for Privosegtor After OCS-01 Phase III Failure

Oculis Holding AG said Privosegtor has dosed its first patient in the PIONEER-1 registrational trial for optic neuritis, according to Jiemian News. The move comes after the company’s OCS-01 eye drop failed to meet the primary and key secondary endpoints in two Phase III studies for diabetic macular edema, prompting Oculis to stop pursuing a U.S. FDA filing for that indication. Jiemian News reported that OCS-01’s DIAMOND-1 and DIAMOND-2 trials missed their main efficacy targets even though OCT data showed sustained reductions in retinal thickness versus placebo. Oculis then shifted its late-stage focus to Privosegtor, which received positive pre-IND feedback from the FDA’s neurology division on August 3 for development in acute multiple sclerosis relapse. The company signed an asset purchase agreement with Accure Therapeutics on August 10 to seek additional rights to Privosegtor, and said it plans to file an IND for the acute multiple sclerosis relapse program in the fourth quarter of 2026. Oculis also said its Licaminlimab dry-eye program had activated all planned study sites in PREDICT-1 as of August 6, with more than 45% of patients randomized, and it expects top-line results around year-end. As of June 30, 2026, the company held $282.3 million in cash, cash equivalents and short-term investments, which it said should fund operations into the second half of 2029.