ST LOUIS (MD Consult) - On May 29, 2009, Bausch & Lomb announced that the US Food and Drug Administration (FDA) approved Besivance (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis, a condition commonly referred to as pink eye. Besivance is a topical ophthalmic preparation, administered via sterile ophthalmic drops, that treats a wide range of eye pathogens including those that most commonly cause bacterial conjunctivitis. According to the manufacturer, Besivance is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use.

The FDA approval of Besivance was granted on the basis of results from 8 clinical trials. These studies were designed to test the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics with the topical antibacterial. The efficacy of Besivance was evaluated in 3 multicenter, randomized, double-masked trials involving nearly 2,400 patients with a clinical diagnosis of bacterial conjunctivitis. Patients receiving the drug in clinical trials had a faster rate of resolution of the infection than patients treated with a solution containing only a preservative. Besivance was shown to be effective in treating patients aged ≥1 year.

Besivance is indicated for the treatment of bacterial conjunctivitis in patients aged ≥1 year whose infection is caused by susceptible isolates of the following bacteria: CDC coryneform group G, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Haemophilus influenzae, Moraxella lacunata, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus lugdunensis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, and Streptococcus salivarius. It should be noted that the efficacy of Besivance against some of these organisms was tested in fewer than 10 infections.

The most frequently reported adverse event in clinical studies of Besivance was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in approximately 1%-2% of patients included blurred vision, headache, and eye pain, irritation, and pruritus.

As with other antiinfectives, prolonged use of Besivance may result in overgrowth of nonsusceptible organisms, including fungi. If super-infection occurs, Besivance should be discontinued and alternative therapy instituted. Although Besivance is not intended to be administered systemically, quinolones administered systemically have been associated with hypersensitivity reactions, even after a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.

圣路易斯(MD Consult)——2009年5月29日，博士伦公司宣布美国食品药品管理局(FDA)批准0.6% Besivance(贝西沙星混悬型滴眼液)用于治疗细菌性结膜炎(俗名“红眼病”)。Besivance是一种局部眼用制剂，加入无菌滴眼剂给药，为针对眼部致病菌(其中包括细菌性结膜炎的最常见致病菌)的广谱抗菌药。据生产商称，Besivance是第一个专用针对眼部研发的氟喹诺酮类药物，也是第一个且惟一一个既往未全身应用的眼用氟喹诺酮类药物。

FDA基于8项临床试验的结果批准Besivance的应用。这些研究旨在检测此局部抗菌药的疗效、安全性、耐药性、药代动力学以及药效动力学。有3项多中心、随机、双盲试验对Besivance的疗效进行了评价，共纳入了近2,400例临床上诊断为细菌性结膜炎的患者。在临床试验中，与接受仅含防腐剂的对照液处置的患者相比，接受Besivance治疗的患者感染消除速率较快。研究表明，Besivance可有效治疗年龄≥1 岁的患者。

Besivance适用于治疗年龄≥1 岁、由下列细菌的致病分离物所致的细菌性结膜炎患者：CDC棒状杆菌G群，假白喉棒杆菌，纹带棒杆菌，流感嗜血杆菌，腔隙莫拉菌，金黄色葡萄球菌，表皮葡萄球菌，人葡萄球菌，路邓葡萄球菌，缓症链球菌群，口腔链球菌，肺炎链球菌以及唾液链球菌。值得一提的是，Besivance针对上述某些细菌的疗效测试是在不足10例的感染患者中进行的。

Besivance的临床研究中患者报告的最常见的不良事件是结膜发红，大约占病例的2%。患者中有1%~2%报告了其他不良事件，其中包括视力模糊、头痛、眼痛、易怒以及瘙痒。

正如其他抗感染药一样，长期应用Besivance可导致真菌等非致病菌过度生长。若发生双重感染，则停用Besivance，选用替代药物治疗。不建议Besivance全身用药，全身应用喹诺酮类药物，即使是单剂治疗，亦可引发超敏反应。应建议患者在首次出现皮疹或过敏反应的征象后，立即停药并与其医生联系。

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