近日，美国食品药品监督管理局（FDA）已批准使用0.1％的Upneeq（oxymetazoline hydrochloride 中文译名：盐酸羟甲唑啉）滴眼液0.1％，以前称为RVL-1201，它是一种用于治疗后天性眼睑下垂或眼睑下垂的新方法，这种疾病的特征是上眼睑异常下垂，可能会限制视野。Upneeq成为FDA批准的唯一上睑下垂药物。
Upneeq将为眼科护理专家提供一个安全、方便的非手术选择来治疗上睑下垂的患者。
批准日期：2020年7月9日 公司：Osmotica Pharmaceuticals plc
UPNEEQ（盐酸甲氧甲唑啉[oxymetazoline hydrochloride]）滴眼液，0.1％，用于外用眼药
美国最初批准：1964年
作用机理
羟甲唑啉是一种α肾上腺素受体激动剂，靶向眼睑Mueller肌肉中的一部分肾上腺素能受体。
适应症和用途
UPNEEQ适用于成人后天性睑裂病的治疗。
剂量和给药
每天向一只或两只下垂眼滴入一滴。
剂量形式和强度
眼药水，以0.1％羟甲唑啉为盐，相当于0.09％羟甲唑啉为碱。
禁忌症
没有。
警告和注意事项
α-肾上腺素能激动剂可能会影响血压。建议患有心血管疾病，体位性低血压和/或高血压或低血压的患者在病情恶化时寻求医疗护理。
在患有脑或冠状动脉供血不足或干燥综合征的患者中谨慎使用，并建议患者在出现血管供血不足增强的体征和症状时就医。
如果出现疼痛，发红，视力模糊和畏光，建议患者立即就医（急性闭角的体征和症状）。
不良反应
最常见的不良反应（发生率1-5％）是：点状角膜炎，结膜充血，干眼，视力模糊，滴注部位疼痛，眼刺激和头痛。
包装供应/存储和处理方式
UPNEEQ（盐酸羟甲唑啉眼药水），含量为0.1％，是无菌制备，无菌，未保存，透明，无色至浅黄色的眼药水；将0.3mL装在铝箔袋中的透明，低密度聚乙烯，单个患者用容器中。
NDC 73687-062-15纸箱，由15个单独的患者用容器单独包装，并用铝箔袋装在一个防儿童的拉链袋中。
NDC 73687-062-32纸箱，每袋有30个单独的患者用容器，每个容器用铝箔袋单独包装，并带有防儿童拉链袋。
存放：存放于20°C至25°C（68°F至77°F）。防止过热。 请将本品放在儿童不能接触的地方。
将装有铝箔袋的患者专用一次性容器存放在可防止儿童进入的原始拉链袋中。使用过的容器应在使用后立即丢弃。
完整说明料附件：
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/0212520s000lbl.pdf
Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq(oxymetazoline hydrochloride ophthalmic solution),0.1% for Acquired Blepharoptosis(Droopy Eyelid)in Adults
U.S. Food and Drug Administration (FDA) has approved Upneeq(oxymetazoline hydrochloride ophthalmic solution), 0.1%, formerly known as RVL-1201, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision. Upneeq becomes the only FDA-approved medical treatment for ptosis.
IMPORTANT SAFETY INFORMATION UPNEEQ(oxymetazoline hydrochloride ophthalmic solution),0.1% is indicated for the treatment of acquired blepharoptosis in adults.
WARNINGS AND PRECAUTIONS
-- Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.-Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop. -- UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop. -- Patients should not to touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.
ADVERSE REACTIONSAdverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.
DRUG INTERACTIONS
-- Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as beta‑blockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy. -- Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.
About Acquired Blepharoptosis
Acquired blepharoptosis, also known as ptosis, or droopy eyelid, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis. The current standard of care is surgery, which is often reserved only for severe cases.
About Upneeq
Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1% is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller’s muscle and elevate the upper eyelid. Upneeq is the first and only FDA-approved pharmacologic treatment indicated for the treatment of acquired blepharoptosis(ptosis, or droopy eyelid).