Ocugen, Inc. a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Company’s Phase 2/3 clinical trial, OCU-002, for COVAXIN (BBV152).
“We’re extremely pleased that we can proceed with our clinical trials for COVAXIN™, our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately.”