FDA批准Jetrea治疗症状性玻璃体黄斑粘连

圣路易斯(MD Consult)——2012年10月18日，美国食品药品管理局(FDA)和ThromboGenics宣布，已批准Jetrea(ocriplasmin)用于治疗症状性玻璃体黄斑粘连(VMA)。Jetrea是首个获得该适应证的药物。

Jetrea是一种酶，可降解眼中参与VMA发生的蛋白质。这些蛋白质的降解有助于玻璃体与黄斑的分离。该病的另一种治疗选择是玻璃体切除术。

Jetrea的安全性和有效性在2项临床研究中得到了确证。这2项研究共招募了652例症状性VMA患者，将其随机分组，给予Jetrea单剂眼内注射或安慰剂治疗。结果显示，Jetrea优于安慰剂(26.5% vs. 10.1%；P＜0.01)。

接受Jetrea治疗的患者报告的最常见不良反应包括飞蚊症、结膜出血、眼痛、闪光幻觉、视力模糊、视力下降、视网膜水肿和黄斑水肿。多数事件为一过性。

推荐的Jetrea剂量为单次注射0.125 mg(0.1 ml)稀释溶液，患眼玻璃体内注射给药。Jetrea的包装规格为一次性玻璃瓶装，0.2 ml溶液中含有药物0.5 mg(2.5 mg/ml)。

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ST LOUIS (MD Consult) - On October 18, 2012, the US Food and Drug Administration (FDA) and ThromboGenics announced the approval of Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). Jetrea is the first pharmacologic agent to be approved for this indication.

Jetrea is an enzyme that breaks down proteins in the eye responsible for VMA. The breakdown of these proteins allows a better separation between the vitreous and macula. The alternative treatment for this condition is vitrectomy.

The safety and effectiveness of Jetrea were established in 2 clinical studies involving 652 patients with symptomatic VMA. Patients were randomly assigned to receive either a single injection of Jetrea into the eye or placebo. The use of Jetrea was shown to be superior to placebo (26.5% vs 10.1%; P < .01).

The most common adverse effects reported in patients treated with Jetrea included eye floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision, unclear vision, vision loss, retinal edema, and macular edema. Most events were transient.

The recommended dose of Jetrea is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection. Jetrea is provided as a single-use glass vial containing 0.5 mg in 0.2 mL solution for intravitreal injection (2.5 mg/mL).

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