近日，其用于治疗眼科手术后眼部疼痛的药物Dextenza（dexamethasone，地塞米松缓释泪点塞）首个获得美国FDA批准。
Dextenza是一种不含防腐剂的泪小管内插物，于眼科手术后插入下泪点进入泪小管，释放皮质类固醇地塞米松用于缓解疼痛，剂量为0.4毫克，给药时间长达30天。由于是可吸收材料制成，一次性放置，无需拆除。
这也是首个获得FDA批准的用于给药的小管内插物。这种给药方式为患者和医生提供了具有革新意义的新产品。眼科手术后频繁滴加眼药对于患者来说既繁琐又困难，而Dextenza的获批可以让医生通过在术后一次性放置插入物来提供类固醇治疗，提高患者术后用药的治疗体验。
批准日期：2018年12月8日 公司：Ocular Therapeutix
DEXTENZA（地塞米松[dexamethasone]）眼用插入物0.4mg，用于颅内使用
最初的美国批准：1958年
作用机制
地塞米松（一种皮质类固醇）已被证明可通过抑制多种炎性细胞因子来抑制炎症，从而导致水肿，纤维蛋白沉积，毛细血管渗漏和炎症细胞迁移。
适应症和用法
DEXTENZA是一种皮质类固醇，用于治疗眼科手术后的眼部疼痛。
剂量和给药
DEXTENZA是一种眼科插入物，插入较低的泪点并进入泪小管。单次DEXTENZA在插入后释放0.4mg剂量的地塞米松长达30天。
剂量形式和强度
眼科腔内插入物含有0.4mg剂量的地塞米松。
禁忌症
活动性眼部感染。
警告和注意事项
•眼压升高：监测眼压。
•细菌感染：类固醇可能掩盖感染迹象，增强现有感染。
•病毒感染：眼部类固醇可延长病程，并可降低眼部病毒感染的严重程度。
•真菌感染：考虑任何持续性角膜溃疡的真菌侵袭。
•延迟愈合：眼部类固醇可能会减慢眼部愈合的速度。
不良反应
最常报告的不良反应是前房炎症和眼压升高。
这些发生在大约5-9％的患者中。
要报告疑似不良反应，请致电1-800-DEXTENZA（339-8369）或FDA 1-800-FDA-1088或www.fda.gov/medwatch联系Ocular Therapeutix。
包装提供/存储和处理
DEXTENZA在铝箔层压袋内的泡沫载体中无菌供应，包含：
NDC 70382-204-10纸箱包含10个小袋（10个插页）
NDC 70382-204-01纸箱包含1个小袋（1个插页）
如果小袋已损坏或破损，请勿使用。
DEXTENZA仅适用于单剂量。
储存：冷藏保存，温度在2°C至8°C（36°F至46°F）之间。 不要冻结。 避光，保持包装直至使用。
完整说明附件：http://www.dextenza.com/wp-content/uploads/2018/12/DEXTENZA-Final-Label-12.1.18.pdf
OCULAR THERAPEUTIX™ ANNOUNCES FDA APPROVAL OF DEXTENZA® FOR THE TREATMENT OF OCULAR PAIN FOLLOWING OPHTHALMIC SURGERY
DEXTENZA(dexamethasone ophthalmic insert) is the First Intracanalicular Insert for Drug Delivery
Ocular Therapeutix to Host Conference Call Today at 8:30 am ET
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.
WARNINGS AND PRECAUTIONS
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during treatment.
Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
ADVERSE REACTIONS
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%).
The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).