Oculis Announces OCS-01 Failed to Meet Primary Endpoints in Phase 3 DME Trials, Abandons NDA Filing

YaoRongQuan DataMonitoring Shows：On May 29, 2026, Oculis Holding AG (NASDAQ:OCS), a global biopharmaceutical company headquartered in Zug, Switzerland, announced itsCore Pipeline OCS-01 Eye Drops (High-Concentration Dexamethasone Ophthalmic) Treatment of Diabetic Macular Edema (DME)the top-line results of two pivotal Phase III clinical studies (DIAMOND-1 and DIAMOND-2). The stock price plummeted on the same day. The latest valuation stands at $700 million.

Neither trial met its primary endpoint, namelyMean Change in Best-Corrected Visual Acuity (BCVA) from Baseline at Week 52; meanwhile, the key secondary endpoint—the proportion of patients with a ≥15-letter improvement in BCVA from baseline at Week 52—was also not met.

Notably, optical coherence tomography (OCT) assessments demonstrated that, compared with the placebo group, the OCS-01 treatment group exhibited significant and sustained reductions in retinal thickness at the majority of visit timepoints. In terms of safety, OCS-01 was generally well tolerated, with no unexpected adverse events observed; only slightly higher incidences of increased intraocular pressure and cataracts were noted in the treatment group.

Based on the above results, the CompanyNo PlanSubmit a marketing application to the U.S. FDA for OCS-01 for the DME indication, and reallocate company resources to prioritize the advancement of two late-stage products: the PIONEER registration program for Privosegtor (OCS-05) for optic neuropathy.Project, and used forLicaminlimab for Dry Eye Disease (anti-TNFα eye drop）PREDICT-1 Registration Trial.

As of March 31, 2026, the Company held cash, cash equivalents, and short-term investments totaling $278 million, which is expected to fund operations through the second half of 2029.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “We are disappointed that although OCS-01 significantly and sustainably reduced retinal edema, this did not translate into improved visual acuity at Week 52. We remain confident in our company’s pipeline and will concentrate resources on advancing two late-stage registration programs.”