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 the requested indication. The Agency stated that the risks of adverse reactions shown for Iluvien® in the FAME Study were significant and were not offset by the benefits demonstrated. The FDA has indicated that the submitting company will need to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication.
In Europe, the ...
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