Safety of Besifloxacin Ophthalmic Suspension 0.6% in Cataract and LASIK Surgery Patients

Abstract

Purpose: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%.

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

“…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.…”

“…In vitro susceptibility testing of baseline isolates recovered from lid margins and conjunctiva of these patients shows that besifloxacin had greater activity for CoNS than vancomycin (MIC 90 : 0.5 vs. 2 μg/mL) and an eightfold lower (better) MIC 90 for MRSE than moxifloxacin. These data, taken together with the lack of postoperative infections reported with besifloxacin use in the surgical setting [ 81 – 85 ], suggest that besifloxacin may effectively reduce ocular surface flora prior to or after surgery.…”

“…Similarly, Parekh et al [ 82 ] found no evidence of adverse drug reactions following besifloxacin or moxifloxacin prophylaxis in a retrospective chart review of more than 700 consecutive cases of routine cataract surgery obtained from nine clinical centers in the US (besifloxacin: n = 493, 89% suture-less; moxifloxacin: n = 253, 78% suture-less) [ 82 ]. Finally, in a prospective, multisite, cataract surgery surveillance study of 485 eyes (besifloxacin: n = 333; moxifloxacin: n = 152) conducted by Majmudar and Clinch [ 85 ], only 1 treatment-emergent adverse event (mild hypersensitivity or allergic reaction) was reported in a besifloxacin case, and this resolved after discontinuation of medication.…”

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).…”

Study of common cytotoxicity of aminoglycoside and fluoroquinolone antibiotics in cell cultures

“…По мере накопления клинического опыта применения АБП и появления новых технологий, используемых как для поиска новых молекул-кандидатов, так и для их тестирования, появляются антибиотики следующих поколений, обладающие улучшенной безопасностью и повышенной эффективностью. С момента появления фторхинолонов IV поколения систематизированных данных о клинических проявлениях их цитотоксичности не публиковалось, что косвенно свидетельствует об улучшенном профиле их безопасности [30,31], тем не менее все еще встречаются единичные клинические случаи, описывающие такие серьезные побочные эффекты, как отек роговицы [32]. При этом акцент озабоченности перенесен на безопасность средств доставки новых молекул, которые также могут вызывать серьезные побочные эффекты, как это было продемонстрировано в случае с биоадгезивной платформой пролонгированной доставки DuraSite, импрегнированной безифлоксацином или азитромицином, в исследовании бесшовного закрытия постоперационных дефектов роговицы [33].…”