The FDA has approved an expanded label for Iluvien, allowing its use for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, ANI Pharmaceuticals announced in a press release. The update enhances treatment options for patients with this vision-threatening condition..

美国食品药品监督管理局（FDA）已批准扩大Iluvien的适应症范围，允许其用于治疗影响眼部后段的慢性非感染性葡萄膜炎，ANI制药公司在新闻稿中宣布。这一更新为患有这种威胁视力疾病的患者增强了治疗选择。

Expanded Indications for Iluvien

Iluvien的扩展适应症

Iluvien (fluocinolone acetonide intravitreal implant) was previously approved for diabetic macular edema (DME) in the U.S. and has been used for both DME and noninfectious uveitis affecting the posterior segment (NIU-PS) in 17 countries across Europe. With this new approval, Iluvien's label has been updated to reflect its broader application, providing an additional option for U.S.

Iluvien（氟轻松乙酸酯玻璃体内植入剂）此前在美国已获批用于治疗糖尿病性黄斑水肿（DME），并在欧洲17个国家被用于治疗DME以及影响后段的非感染性葡萄膜炎（NIU-PS）。随着此次新批准，Iluvien的适应症标签已更新，反映了其更广泛的应用，为美国提供了另一种选择。

patients dealing with NIU-PS..

处理NIU-PS的患者..

Strengthening Market Access and Supply

加强市场准入和供应

ANI Pharmaceuticals plans to initiate marketing under the combined label later this year, ensuring greater accessibility for patients. Additionally, the company has reinforced its partnership with Iluvien's contract manufacturer, Siegfried Holding, extending their supply agreement through 2029.

ANI制药公司计划在今年晚些时候在合并标签下启动市场推广，确保患者获得更大的可及性。此外，该公司还加强了与Iluvien的合同制造商齐格弗里德控股公司的合作关系，将供应协议延长至2029年。

Industry Perspective

行业视角

“Iluvien’s expanded label and the strengthening of our partnership with long-standing Iluvien contract manufacturer, Siegfried, will enhance supply security and access for appropriate NIU-PS and DME patients in need,” said Nikhil Lalwani, president and CEO of ANI Pharmaceuticals.

“伊鲁维恩标签的扩展以及我们与长期合作伙伴、伊鲁维恩合同制造商西格弗里德关系的加强，将提高需要治疗的非感染性葡萄膜炎后段（NIU-PS）和糖尿病黄斑水肿（DME）患者的供应安全性和可及性，”ANI制药公司总裁兼首席执行官尼基尔·拉尔瓦尼表示。

Conclusion

结论

The FDA’s approval marks an important step in broadening the therapeutic reach of Iluvien, offering new hope for patients with NIU-PS while solidifying ANI Pharmaceuticals’ presence in the ophthalmic treatment landscape.

美国食品药品监督管理局（FDA）的批准标志着扩大Iluvien治疗范围的重要一步，为患有NIU-PS的患者提供了新的希望，同时也巩固了ANI制药公司在眼科治疗领域的地位。