Oculis Shelves FDA Filing After Phase 3 DME Trials Miss Key Vision Goals

Oculis said both Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema failed to meet their primary endpoints, a material setback for the program. The company also said it does not currently plan to pursue a U.S. FDA filing for the drug in this indication, reducing the near-term commercialization outlook.

Analysis

Oculis said both Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema failed to meet their primary endpoints, a material setback for the program. The company also said it does not currently plan to pursue a U.S. FDA filing for the drug in this indication, reducing the near-term commercialization outlook.