Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has sent a complete response letter (CRL) to Alimera Sciences' new drug application ( NDA) for Iluvien.
Subscribe to our email newsletter
Iluvien is the company’s investigational sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide (FAc) to treat diabetic macular edema (DME) associated with diabetic retinopathy.
FDA did not approve the Iluvien because its NDA did not provide sufficient data to support that Iluvien is safe and effective to treat DME patients.
FDA said the benefits showed by Iluvien in these clinical trials were not satisfied, where as the risks of adverse reactions shown for Iluvien in the Fame Study were significant.
Further, FDA indicated Alimera to conduct two additional clinical trials to assess that the product is safe and effective.
Alimera president and CEO Dan Myers said they are committed to, and have the funds for, pursuing approval in Europe and for evaluating their options in the US.