NSAID滴眼液Prolensa获准用于白内障手术患者

圣路易斯(MD Consult)——2013年4月8日，博士伦公司宣布，美国食品药品管理局(FDA)已批准处方药滴眼液Prolensa(溴芬酸眼用溶液)0.07%用于接受白内障手术的患者, 治疗其术后炎症和减轻其眼部疼痛。Prolensa被认为是一种非甾体抗炎药(NSAID)，用法为每日1次。

Prolensa的有效性在2项针对接受白内障手术的患者的随机、双盲、安慰剂对照研究中得到了评估。这2项研究均将受试者分为Prolensa组和安慰剂组，初始剂量为手术前和手术当天术眼每日1滴，术后使用14天。主要疗效终点是在第15天之前完全清除眼部炎症。次要疗效终点为术后首日无痛的受试者比例。

来自关键研究的结果显示，Prolensa在治疗白内障手术后炎症和缓解疼痛方面均优于安慰剂。接受Prolensa治疗的患者在第15天时完全没有炎症的比例达安慰剂组的2倍以上(46% vs. 20%)。第8天时，两组患者的平均术后炎症严重程度兼有统计学显著性和临床显著性。接受Prolensa治疗的患者近4/5在术后第1天无疼痛(78.8% vs. 49.5%；P＜0.0001)。接受Prolensa治疗的患者较少报告异物感和畏光，红肿也少于安慰剂组患者。

Prolensa组患者报告的最常见不良反应为前房炎症、异物感、眼痛、畏光和视力模糊。

Prolensa含有soldium sulfite，后者可导致易感患者发生过敏反应。

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ST LOUIS (MD Consult) - On April 8, 2013, Bausch and Lomb announced that the US Food and Drug Aministration (FDA) has approved Prolensa (bromfenac ophthalmic solution) 0.07% prescription eye drops for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Prolensa is considered a nonsteroidal anti-inflammatory drug (NSAID) and is administered once daily.

The efficacy of Prolensa was evaluated in 2 randomized, double-masked, vehicle-controlled studies of patients undergoing cataract surgery. Each randomly assigned patient received Prolensa or vehicle starting with a dose of 1 drop into the surgical eye on the day before and the day of surgery, and for 14 days after surgery. The primary efficacy end point was complete clearing of ocular inflammation by day 15. The secondary efficacy end point was the number of participants that were pain free on postoperative day 1.

Results from the pivotal studies showed that Prolensa was superior to vehicle in the treatment of both inflammation and pain after cataract surgery. Twice as many patients who received Prolensa versus vehicle (46% vs 20%) demonstrated complete clearance of inflammation at day 15. The difference in the average postoperative inflammation severity between the treatment and vehicle arms was statistically and clinically significant by day 8. Nearly 4 of 5 patients treated with Prolensa were pain free at day 1 (78.8% vs 49.5% for vehicle; P < .0001). Patients treated with Prolensa reported a lower incidence of foreign-body sensation and photophobia and demonstrated less redness than patients treated with vehicle.

The most common adverse reactions reported with the use of Prolensa were anterior chamber inflammation, foreign-body sensation, eye pain, photophobia, and blurred vision.

Prolensa contains soldium sulfite, which may cause allergic reactions in susceptible individuals.

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