Use of Besifloxacin Ophthalmic Suspension 0.6% in Treatment of Bacterial Keratitis

Friday, April 25, 2014
KIOSKS (Boston Convention and Exhibition Center)
Barry A. Schechter, MD, Florida Eye Microsurgical Institute, Boynton Beach, Florida, USA
William B. Trattler, MD, Center For Excellence In EyeCare, Miami, FL, USA
Jai G. Parekh, MD, MBA, Brar-Parekh Eye Associates, NJ, woodland park, NJ, USA

Narrative Responses:

Purpose
Besifloxacin is indicated for the treatment of bacterial conjunctivitis but has been used off-label to treat bacterial keratitis. Our objective was to collect and evaluate retrospective safety data about the use of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial keratitis.

Methods
This was a retrospective surveillance of bacterial keratitis cases conducted at 10 clinical centers across the USA. Cases included patients treated with besifloxacin ophthalmic suspension 0.6% for bacterial keratitis in one or both eyes. For perspective, data from patients treated with moxifloxacin ophthalmic solution 0.5% were also included. Investigators provided outcome information and reported any adverse events (AEs) related to the antibacterial used. The primary endpoint was the incidence of adverse drug reactions. Other outcomes included corneal scarring, corneal neovascularization, bacterial eradication, visual acuity and duration of pain.

Results
A total of 227 case reports (227 eyes: 142 besifloxacin, 85 moxifloxacin) were reviewed. More than half of infected patients wore contact lenses,  most epithelial defects were small. Approximately one third of patients were treated with a maximum dose frequency of five or more times per day,  the median duration of antibiotic treatment was 15 days. There was one reported AE of mild superficial punctate keratitis in a patient using besifloxacin. The reported rate of bacterial eradication was >90% in both treatment groups. Additional outcomes were similar between treatment groups (P≥0.208).

Conclusion
The retrospective data suggests that besifloxacin ophthalmic suspension 0.6% was well tolerated for treatment of keratitis with no serious AEs reported. Bacterial eradication rates were above 90%.