Safety of besifloxacin ophthalmic suspension 0.6% in refractive surgery: a retrospective chart review of post-LASIK patients

Abstract

BackgroundTo evaluate the safety of besifloxacin ophthalmic suspension 0.6% when used in laser-assisted in situ keratomileusis (LASIK) prophylactic antibiotic regimens.MethodsRetrospective surveillance of LASIK surgery cases where besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% were prescribed as prophylactic medications. Surgeons from nine US surgical centers provided retrospective case information on surgical outcomes from consecutive cases and reported any adverse events related to the antibacterial used. The primary endpoint was the incidence of adverse drug reactions.ResultsA total of 801 case reports (801 eyes; 534 besifloxacin, 267 moxifloxacin) were obtained. The mean (standard deviation [SD]) age at time of surgery was 36.1 (10.6) years. The mean (SD) duration of antibiotic treatment was 8.6 (2.2) days in the besifloxacin group and 8.0 (2.3) in the moxifloxacin group; daily dosing frequency was higher in the moxifloxacin group preoperatively, on the day of surgery, and postoperatively. There were no reports of adverse drug reactions for the 801 eyes in this surveillance. There were no differences between the besifloxacin and moxifloxacin treatment groups in rates of unexpected corneal findings (2.1% vs 1.5%, P = 0.949). The distribution of final visual acuity for the besifloxacin and moxifloxacin groups were similar (P = 0.793). Most cases had a final visual acuity of 20/20 or better.ConclusionIn this retrospective surveillance study, the prophylactic use of besifloxacin ophthalmic suspension 0.6% and moxifloxacin ophthalmic solution 0.5% in patients undergoing LASIK surgery was not associated with any adverse drug reactions.

Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections

“…The safety of besifloxacin for antibacterial prophylaxis in ocular surgery has been studied to a greater extent. A retrospective chart review of 801 laser-assisted in situ keratomileusis (LASIK) cases found that perioperative use of besifloxacin ( n = 534; 2–4 times daily, mean treatment duration: 8.6 days) and moxifloxacin ophthalmic solution 0.5% ( n = 267; 4 or more times daily, mean treatment duration: 8.0 days) in patients undergoing LASIK surgery was not associated with any adverse drug reaction [ 83 ]. Similarly, a recent prospective, multisite, LASIK safety surveillance study by Majmudar and Clinch [ 85 ] suggested besifloxacin appears safe for surgical prophylaxis; among the 456 study eyes (besifloxacin: n = 344; moxifloxacin, n = 112), no treatment-emergent adverse events were reported.…”

Antibacterial efficacy of prophylactic besifloxacin 0.6% and moxifloxacin 0.5% in patients undergoing cataract surgery

“…Several studies have examined the safety of besifloxacin ophthalmic suspension 0.6% compared with that of moxifloxacin ophthalmic solution 0.5% when used for prophylaxis against infections in cataract patients, 50 – 52 laser-assisted in situ keratomileusis patients, 52 , 53 and in patients undergoing photorefractive keratectomy. 54 Results from these studies using preoperative and/or postoperative dosing regimens showed that both antibacterials were well tolerated, with no safety concerns and no differences between treatments in surgical outcomes (data not shown).…”