Ocugen announces IND in effect after FDA review

Ocugen (OCGN) announced that the U.S. FDA has reviewed the company’s Investigational New Drug application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500-an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalation into the lungs and intranasally as a spray. A Phase 1 clinical trial is anticipated to start in 2Q.