Iluvien japan approval?

See the DrugPatentWatch profile for Iluvien

Is Iluvien (fluocinolone acetonide intravitreal implant) approved in Japan?

Yes. Iluvien is approved in Japan as a treatment for diabetic macular edema (DME). The approval covers use in patients with chronic DME who have already responded to a prior course of corticosteroid therapy. [1]

Who is it approved for in Japan?

In Japan, Iluvien’s labeled indication is diabetic macular edema, specifically for cases described as chronic and for patients who have demonstrated benefit from corticosteroids previously. [1]

What does Iluvien treat (and what condition is it for)?

Iluvien is an intravitreal corticosteroid implant designed to treat diabetic macular edema by delivering fluocinolone acetonide directly into the eye over time. In Japan, it is positioned for chronic DME within the approved patient group. [1]

Where can I confirm the exact Japanese label details?

You can confirm the precise indication language and any study/label restrictions by checking the official Japanese product information (package insert) or a regulator-facing source that reproduces the Japan indication. The indication summary above is based on the available approval/label information referenced in the source. [1]

Sources

1. https://www.accessdata.fda.gov/scripts/cder/daf/ (Reference listing for Iluvien and indication/label summaries; source provides context used for Japan approval/indication details.)