FDA approves expanded label for Iluvien
Key takeaways:
- Iluvien is now indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment.
- ANI Pharmaceuticals plans to begin marketing the expanded label later this year.
The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, according to a press release from ANI Pharmaceuticals.
The approval updates the warnings and precautions section of the label for Iluvien (fluocinolone acetonide intravitreal implant), which is also indicated for diabetic macular edema in the U.S. Iluvien previously received approval for DME and noninfectious uveitis affecting the posterior segment (NIU-PS) in 17 countries in Europe.
The company aims to initiate marketing for the implant under the combined label in the U.S. later this year. ANI previously extended its supply agreement for Iluvien with a subsidiary of Siegfried Holding through 2029, according to the release.
“Iluvien’s expanded label and the strengthening of our partnership with long-standing Iluvien contract manufacturer, Seigfried, will enhance supply security and access for appropriate NIU-PS and DME patients in need,” Nikhil Lalwani, president and CEO of ANI, said in the release.
Perspective
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So, in addition to its original U.S. label for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in IOP, Iluvien can also be used for the management of chronic noninfectious posterior uveitis.
For retinal physicians who manage both DME and noninfectious posterior uveitis, this new indication may simplify their treatment paradigm, inventory, revenue cycle management and patient discussions.
Because Iluvien has been approved for DME for several years now, this experience gives physicians the familiarity and awareness of its clinical behavior for that common indication. It will now also serve as a nice addition to our expanding posterior uveitis treatment armamentarium.
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