ciprofloxacin + dexamethasone (CEOLIA Pharma)

ENT103 is a topical otic combination therapy consisting of the fluoroquinolone antibiotic ciprofloxacin and the corticosteroid dexamethasone. Developed by CEOLIA Pharma, it is currently in Phase 3 clinical development in Japan for the treatment of suppurative otitis media, including both acute and chronic forms accompanied by persistent or prolonged otorrhea. Ciprofloxacin provides broad-spectrum antibacterial activity by inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential for DNA replication and transcription. Dexamethasone serves as an anti-inflammatory agent, binding to the glucocorticoid receptor to modulate gene expression and reduce the inflammatory response, thereby alleviating swelling and discharge in the ear. This combination approach aims to address both the underlying bacterial infection and the associated inflammation in patients with difficult-to-treat otorrhea.