The NDA seeks approval to market Iluvien (fluocinolone acetonide intravitreal insert), an investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular oedema (DME).
In the CRL, the FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of Iluvien, which Alimera reports it is in the process of compiling.
In its CRL, the FDA has informed the company that its NDA cannot be approved in its present form and asked for analysis of safety and efficacy data through month 36 of the Fame Study, including exploratory analysis in addition to those previously submitted in the NDA, to further assess the relative benefits and risks of Iluvien.
Alimera has completed 36th month of the FAME Study and has reported that it is preparing the analysis that the FDA has requested.
