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 is the regulatory body that Oculis will not pursue a filing with for its drug candidate OCS-01, following the failed clinical trials.

Oculis: Oculis is the subject of a securities fraud investigation by multiple law firms after its lead drug candidate, OCS-01, failed to meet primary endpoints in late-stage trials, causing a significant drop in its stock price. The company's decision not to pursue an FDA filing for OCS-01 further negatively impacts its market standing.

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.