FDA requests further data on Iluvien® (fluocinolone acetonide intravitreal implant) for diabetic macular oedema

Source: BioSpace
Area: News
According to BioSpace, the US FDA has issued a complete response letter regarding a New Drug Application (NDA) for Iluvien® (fluocinolone acetonide) for the treatment of diabetic macular oedema associated with diabetic retinopathy.  Iluvien® is an investigational extended-release intravitreal insert that releases sustained sub-microgram levels of fluocinolone acetonide (FAc) over up to 36 months.    In the letter, the FDA states that it is unable to approve the application as it stands, as it does not provide sufficient data to support its safety and efficacy in (Read more...)

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