United States — Food and Drug Administration & Oculis

United States — Food and Drug Administration: The United States — Food and Drug Administration granted Breakthrough Therapy designation for Privosegtor, a key regulatory milestone that accelerates its development and potential approval.

Oculis: Oculis is presenting its Privosegtor program at a major clinical trials summit, highlighting its progress in developing a potential neuroprotective therapy for optic neuritis, which could significantly benefit the company.

United States — Food and Drug Administration: The United States — Food and Drug Administration granted Breakthrough Therapy designation to Oculis's Privosegtor, highlighting its potential.

Oculis: Oculis will present its late-stage portfolio and pipeline updates at the conference, potentially increasing investor interest and its stock value.

United States — Food and Drug Administration: Oculis decided not to pursue an FDA regulatory filing for OCS-01 in DME due to the trial results, meaning the drug will not be available in the United States for this indication.

Oculis: Oculis announced that its OCS-01 eye drops failed to meet the primary endpoint in Phase 3 trials for diabetic macular edema (DME), leading to a decision not to pursue FDA regulatory filing for this indication. This negatively impacts Oculis's stock and future revenue expectations for OCS-01 in DME.

United States — Food and Drug Administration: Oculis decided not to pursue an FDA filing for its drug candidate after the failure of its DIAMOND trials, indicating the agency's role in drug approval processes.

Oculis: Oculis is facing an investigation for securities fraud after its lead drug candidate, OCS-01, failed two late-stage trials, causing a significant drop in its stock price.