Xiidra(lifitegrast ophthalmic solution)5%眼药水被FDA批准治疗干眼症
近日，Xiidra(lifitegrast)眼药水已经被美国食品和药物管理局批准用于治疗干眼症状的疾病,这种疾病与眼泪分泌不足有关。
随着年龄的增长出现症状的几率增加。干眼影响大约5%的30到40岁的成年人和15%的人超过65岁,美国食品和药物管理局周二在一个新闻发布会上说。FDA的药品评价和研究中心中抗微生物产品室主任Edward Cox，M.D.说：“对清晰视力和眼健康需要正常的泪液生产，” “这个批准将对干眼病患者提供一种新的治疗选择。”优先审评。
不及时治疗,干眼可以导致疼痛、溃疡或疤痕眼称为角膜的一部分。它可以使它更难以阅读一本书或盯着电脑屏幕,并可能在非常干燥的环境中尤其明显,如在飞机上,该机构说。
临床研究涉及1000多人发现,那些接受Xiidra看到改善干眼的症状,服用安慰剂的人相比。Xiidra是第一个批准药物之间的一个新类干眼病的药物称为淋巴细胞抗原受体激动剂关联。最常见的副作用包括眼睛刺激性、视力模糊和不寻常的味觉。
药物尚未评估在17岁以下的儿童,因为干眼很少影响这个年龄段,FDA说。Xiidra是在美国麻省Lexington的Shire US有限公司制造。
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XIIDRA safely and effectively. See full prescribing information for XIIDRA.
XIIDRA™ (lifitegrast ophthalmic solution) 5%, for topical ophthalmic use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). (1)
DOSAGE AND ADMINISTRATION
One drop twice daily in each eye (approximately 12 hours apart). (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing lifitegrast 5% (50 mg/mL). (3)
CONTRAINDICATIONS
None (4)
ADVERSE REACTIONS
The most common adverse reactions (incidence 5-25%) following the use of Xiidra were instillation site irritation, dysgeusia and decreased visual acuity. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-1088 or www.fda.gov./medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
Xiidra™ (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
2 DOSAGE AND ADMINISTRATION
Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container. Discard the single-use container immediately after using in each eye.
Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.
3 DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing lifitegrast 5% (50 mg/mL).
4 CONTRAINDICATIONS
None.
6 ADVERSE REACTIONS
6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In five clinical studies of dry eye d |
