Comlex

Comlex is a 1.5% levofloxacin hydrate otic solution developed by CEOLIA Pharma for the treatment of bacterial ear infections, including chronic suppurative otitis media (CSOM) and acute otitis media (AOM). As a fluoroquinolone antibiotic, it exerts its bactericidal effect by inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential enzymes for bacterial DNA replication, transcription, and repair. Approved in Japan in 2023, Comlex demonstrated significant efficacy in Phase III clinical trials conducted across multiple institutions, showing high bacterial eradication rates and significant improvement in middle ear and tympanic membrane inflammation. The formulation is administered topically as ear drops twice daily for up to 10 days and is safe and well-tolerated.

Brand names

Comlex

Other names

Levofloxacin hydrate 1.5% ear dropsLevofloxacin (otic)