Amneal Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved its prednisolone acetate ophthalmic suspension, 1%, a sterile topical anti-inflammatory agent intended for steroid-responsive ocular inflammation.

Amneal Pharmaceuticals宣布，美国食品药品监督管理局（FDA）已批准其1%醋酸泼尼松龙眼用混悬液，这是一种用于治疗类固醇反应性眼部炎症的无菌局部抗炎药。

Product Overview and Brand Reference

产品概述与品牌参考

The newly approved formulation references Pred Forte, a well-known corticosteroid eye drop. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company.

新批准的配方参考了Pred Forte，一种知名的皮质类固醇滴眼液。Pred Forte及其设计是艾伯维公司旗下Allergan公司的商标。

Amneal’s product offers an additional FDA-approved option for clinicians managing ocular inflammation that responds to corticosteroids, such as post-surgical inflammation or uveitis.

Amneal的产品为临床医生管理对皮质类固醇有反应的眼部炎症（如术后炎症或葡萄膜炎）提供了另一种FDA批准的选择。

Executive Commentary on the Approval

批准的执行评论

Andy Boyer, Executive Vice President and Chief Commercial Officer of Affordable Medicines at Amneal, highlighted the significance of the approval:

安尼尔公司平价药品执行副总裁兼首席商务官安迪·博伊尔强调了此次批准的重要性：

“Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the U.S. healthcare system. The approval of prednisolone acetate ophthalmic suspension—a complex product to develop and manufacture—highlights the depth of our R&D capabilities and the strength of our manufacturing and supply operations.”.

“我们不断增长的平价药品组合，凭借强大而多样化的产品线，支持了美国医疗系统中更广泛的高质量治疗获取。醋酸泼尼松龙眼科混悬液的获批——这一复杂且难以开发和生产的产品——彰显了我们研发能力的深度以及生产和供应链运营的实力。”

Amneal’s Affordable Medicines segment spans a wide array of complex products, including injectables and biosimilars, with a strong emphasis on access and affordability in U.S. healthcare.

Amneal的平价药品部门涵盖了一系列复杂的产品，包括注射剂和生物类似药，并重点关注美国医疗保健领域的可及性和可负担性。

Commercial Launch and Safety Profile

商业发布与安全概况

The U.S. commercial launch of prednisolone acetate ophthalmic suspension is scheduled for Q3 of 2025. As with other corticosteroid eye treatments, clinicians should monitor patients closely for adverse effects.

美国商业推出醋酸泼尼松龙眼科混悬液的时间定于2025年第三季度。与其他皮质类固醇眼部治疗一样，临床医生应密切监测患者是否出现不良反应。

The most commonly reported side effects in clinical studies include:

临床研究中报告的最常见的副作用包括：

• Elevation of intraocular pressure (IOP), with the potential risk of glaucoma

• 眼内压（IOP）升高，可能导致青光眼风险

• Infrequent cases of optic nerve damage

• 视神经损伤的罕见病例

• Posterior subcapsular cataract formation

• 后囊下白内障形成

• Delayed wound healing

• 伤口愈合延迟