FDA Approves Amneal Pharmaceuticals’ Cyclosporine Ophthalmic Emulsion 0.05%

FDA批准了Amneal制药公司的0.05%环孢素眼用乳剂

December 04, 2025

2025年12月4日

The U.S. Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05%, a generic version of Restasis, which is a registered trademark of Allergan, an AbbVie company. This formulation is indicated to increase tear production in patients with dry eye disease, where tear production is believed to be reduced due to ocular inflammation.

美国食品药品监督管理局（FDA）已批准Amneal Pharmaceuticals公司的0.05%环孢素眼科乳剂，这是艾尔建（Allergan，艾伯维公司旗下企业）注册商标Restasis的仿制药。该配方适用于因眼部炎症导致泪液分泌减少的干眼症患者，以增加泪液分泌。

It is noted that increased tear production was not observed in patients currently using topical anti-inflammatory drugs or punctal plugs..

注意，目前使用局部抗炎药或泪点塞的患者未观察到泪液分泌增加。

Generic Alternative for Dry Eye Disease

干眼病的通用替代疗法

Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator used to address tear deficiency in dry eye syndrome, a condition that affects a large portion of the adult population in the United States. This approval provides an alternative to existing therapies, contributing to broader access in ophthalmic care..

环孢素眼用乳剂0.05%是一种局部免疫调节剂，用于治疗干眼症中的泪液缺乏问题，这一病症影响着美国大部分成年人口。该批准为现有疗法提供了另一种选择，有助于更广泛地获取眼科护理。

Commentary on Market Expansion

市场扩张评论

Srinivas Kone, PhD, Senior Vice President and Chief Scientific Officer at Amneal’s Affordable Medicines division, commented on the approval:

阿姆内尔平价药物部门高级副总裁兼首席科学官斯里尼瓦斯·科内博士就此次批准发表了评论：

“Dry eye disease affects millions of adults in the United States and can significantly impact their quality of life. We are proud to bring another difficult-to-manufacture ophthalmic product to market, reinforcing Amneal’s strong execution in complex formulations and our expanding leadership in ophthalmology within the Affordable Medicines segment.

“干眼病影响着美国数百万成年人，显著影响他们的生活质量。我们很自豪能够将另一款难以生产的眼科产品推向市场，这进一步巩固了Amneal在复杂配方方面的强大执行力，以及我们在平价药品领域中眼科领域的领导地位。”

Cyclosporine joins a series of recent approvals across inhalation, injectable, and ophthalmic categories, underscoring Amneal’s strong execution in high-quality sterile manufacturing.”.

环孢素是近期在吸入、注射和眼科类别中获得批准的产品系列之一，突显了Amneal在高质量无菌制造方面的强大执行力。

Amneal has been expanding its offerings across several product categories, including inhalation, injectable, and ophthalmic medicines, supported by its sterile manufacturing capabilities.

Amneal一直在扩大其在多个产品类别的供应，包括吸入剂、注射剂和眼科药物，这些都得益于其无菌制造能力的支持。