title: Safety of besifloxacin ophthalmic suspension 0.6% in cataract and LASIK surgery patients.
abstract: OBJECTIVE
  The aim of the study was to evaluate the safety of besifloxacin ophthalmic suspension 0.6% as antibacterial prophylaxis in the surgical setting.
  
  
  METHODS
  Two prospective safety surveillance studies were conducted-one in the cataract surgery setting and the other in the laser-assisted in situ keratomileusis (LASIK) surgery setting. Cases from patients aged 18 years and above were eligible for inclusion. In both surveillance studies, data were collected from consecutive cases of routine primary cataract surgery and LASIK surgery, respectively, in which besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% was used as the topical perioperative prophylactic antibacterial medication as part of the clinician's routine standard of care. The primary safety endpoint was the incidence of treatment-emergent adverse events (TEAEs).
  
  
  RESULTS
  The cataract surgery surveillance study included 485 cases/eyes (besifloxacin, n = 333; moxifloxacin, n = 152), whereas the LASIK surveillance study included 456 cases/eyes (besifloxacin, n = 344; moxifloxacin, n = 112). In the cataract study, only 1 TEAE was reported in a besifloxacin case (mild hypersensitivity/allergic reaction considered possibly related to besifloxacin). No TEAEs were reported in the LASIK study. In both studies, surgical outcomes were similar with both treatments. The frequency of preoperative and/or postoperative dosing was generally lower for besifloxacin than that for moxifloxacin.
  
  
  CONCLUSIONS
  In prospective safety surveillance studies of patients undergoing cataract extraction or LASIK, TEAEs associated with prophylactic use of besifloxacin ophthalmic suspension 0.6% were rare, and surgical outcomes with besifloxacin were similar to those with moxifloxacin ophthalmic solution 0.5%.
authors.affiliation: *Chicago Cornea Consultants, Ltd, Hoffman Estates, Chicago, IL; †Eye Doctors of Washington, Chevy Chase, MD; and ‡Eye Doctors of Washington, Washington, DC.
authors.forename: Parag A
authors.initials: PA
authors.lastname: Majmudar
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Clinch
mesh_terms: D000328:Adult; D000368:Aged; D019072:Antibiotic Prophylaxis; D001381:Azepines / Q000009:adverse effects / Q000627:therapeutic use*; D062665:Epidemiological Monitoring; D015818:Eye Infections, Bacterial / Q000517:prevention & control*; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D020731:Keratomileusis, Laser In Situ; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D011446:Prospective Studies; D013535:Suspensions; D059005:Topoisomerase II Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D001381:Azepines; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D013535:Suspensions; D059005:Topoisomerase II Inhibitors; C522124:besifloxacin; D000077266:Moxifloxacin