ST LOUIS (MD Consult) - On August 31, 2010, Allergan announced that the US Food and Drug Administration (FDA) has approved Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lumigan 0.01% is an optimized reformulation of previously approved Lumigan (bimatoprost ophthalmic solution) 0.03%.

In a 3-month study of patients with open-angle glaucoma or ocular hypertension with an average baseline IOP measurement of 23.5 mm Hg, treatment with Lumigan 0.01% lowered IOP up to 7 mm Hg from baseline

 

In clinical studies with bimatoprost ophthalmic solutions (using 0.01% or 0.03% concentrations) the most common adverse event was conjunctival hyperemia (range, 25%-45%). Approximately 0.5% to 3% of patients discontinued therapy as a result of this event. Other common events (>10%) included growth of eyelashes and ocular pruritus.

Lumigan 0.01% is administered once daily in the evening, with a recommended dosage of 1 drop in each affected eye. More frequent dosing of Lumigan is not recommended.

 

圣路易斯(MD Consult)——2010年8月31日，美国眼力健(Allergan)公司宣布，美国食品药品管理局(FDA)已经批准浓度为0.01%的卢美根滴眼液(Lumigan，贝美前列素滴眼液)用作降低开角型青光眼或高眼压症患者高眼压(IOP)的一线治疗。0.01%卢美根滴眼液是之前获准的0.03%卢美根滴眼液(贝美前列素滴眼液)经优化的新配方。

 

一项对开角型青光眼或高眼压症(基线IOP平均值为23.5 mmHg)患者进行的为期3个月的研究表明，受试者在接受0.01%卢美根滴眼液治疗后，其IOP自基线水平下降达7 mmHg。

 

在有关贝美前列素滴眼液(浓度为0.01%或0.03%)的临床研究中，最常见的不良事件是结膜充血(发生率范围为25%~45%)。有0.5%~3%的患者因为此不良事件而停止治疗。其他常见的不良事件(>10%)有睫毛增生和眼部瘙痒。

 

0.01%卢美根滴眼液的用法为：每只患眼的推荐剂量为1滴，晚上用药，每日1次。不推荐增加卢美根滴眼液的用药次数。