Intraocular inflammation (IOI) in combined OAKS and DERBY clinical trials2
- Upon trial initiation, four IOI cases (including 1 case of noninfectious endophthalmitis) were observed and linked to drug impurity2
- The trials were placed on voluntary hold
- The drug impurity was removed, and the trials resumed
- Four cases of infectious endophthalmitis were reported through Year 22*
*Total does not include 1 incident of endophthalmitis with negative vitreous culture results in the EOM group
that appeared to be associated with an impurity in the drug product lots at the beginning of the study, which
has been successfully removed by optimization of the manufacturing process.2
EOM=every other month.