A Benefit-Risk Assessment of Ofloxacin Otic Solution in Ear Infection

Ear infections, including otitis externa, chronic suppurative otitis media and otorrhoea associated with tympanostomy tubes, are common problems in clinical practice. The potential complications associated with ear infection can be otological, extratemporal, or even psychosocial. They are sometimes fatal and the effect can be long-lasting and detrimental. The use of an effective topical antibacterial with high cost-effectiveness is definitely warranted. As regards various clinical aspects, including overall success rate, symptomatic relief of otalgia and otorrhoea, ofloxacin otic solution was found to be more effective than comparator agents, be it a topical antibacterial, a systemic antibacterial or combination drugs.

The systemic absorption of fluoroquinolones is minimal after topical application. Ofloxacin otic solution 0.3% has been shown to have a low rate of adverse drug reactions. Adverse reactions to ofloxacin otic solution were generally mild. The lack of ototoxic effect from ofloxacin eardrops, even in the concentration higher than 0.3%, has been demonstrated in animal studies. In the clinical setting, no increase in bone-conduction threshold has been shown after the treatment of topical ofloxacin otic solution. There have not been any reports of ototoxicity with ofloxacin otic solution since its approval.

To conclude, ofloxacin otic solution 0.3% is clinically effective in the treatment of otitis externa and chronic suppurative otitis media in particular with respect to the overall cure rate, relief of otalgia and otorrhoea. It is well tolerated, with minimal adverse effects. It is not associated with any ototoxicity both experimentally and clinically.