Abstract
A new fixed-dose combination of dexamethasone and levofloxacin eye drops has recently been approved for the prevention and treatment of inflammation, and the prevention of infection associated with cataract surgery in adults. This combination has been developed to respond to a series of unmet needs in the practical management of patients undergoing cataract surgery. Namely, despite updated guidelines, many ophthalmologists employ protocols mainly based on their personal experience. As a result, the choice of drugs, treatment duration, and drug association is not evidence-based medicine (EBM)-oriented. In addition, antibiotic resistance may occur since antibiotics are used for an extended length of time, even with tapering. Corticosteroids are also prescribed for prolonged periods, frequently without follow-up. Therefore, patient adherence to postsurgical self-care is low, and mainly affects older patients who are the majority undergoing cataract surgery. In both rabbit and human trials, it has been demonstrated that both active ingredients penetrate the ocular system without pharmacokinetic interaction between the two. The concentrations of both ingredients in aqueous humor after their ocular instillation are high enough at the site of action to carry out their expected potent anti-inflammatory and antibiotic activity. Tested in a pivotal study aimed at investigating efficacy and safety of the intended indication, the mixture/compound was non-inferior to a 2-week treatment with dexamethasone/tobramycin in preventing or reducing inflammation and in preventing infection when administered for 1 week, followed by the administration of dexamethasone alone for another week. The outcomes obtained by this study suggest that a 1-week course of levofloxacin/dexamethasone eye drops is sufficient to resolve inflammation and prevent infection in patients undergoing cataract surgery. In addition, this study underlines that a follow-up visit after 1 week allows for a decision about whether to stop or continue a treatment in patients still experiencing symptoms or inflammation. In conclusion, this new dose combination could represent a turning point in managing patients after cataract surgery, while mostly avoiding antibiotic resistance and improving treatment adherence.
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