Investigational drug Iluvien (fluocinolone acetonide intravitreal insert) for the treatment of diabetic macular edema cannot be approved in its present form, the FDA (Food and Drug Administration) wrote in its Complete Response Letter (CRL). Illuven is the result of a collaboration between pSdivida Corp. and Alimera Sciences Inc.
The New Drug Application (NDR) is sought to market Iluvien, an experimental, sustain drug delivery system releasing sub-microgram levels of fluocinolone acetonide for DME (diabetic macular edema). On June 29th, the Ilivien’s NDA, containing 24-months’ worth of safety and efficacy data from the FAME Study, was submitted to the FDA. NDA Priority Review status was subsequently granted at the end of August this year.
The FDA says it now requires 36-months’ worth of safety and efficacy data from the FAME study, as well as exploratory analyses. The Agency says only then can it properly compare the health costs and benefits of Iluvien.
Alimera and pSdivida says they have completed the 36-month FAME Study data the FDA requires, and are currently preparing the analyses. A meeting with the FDA has been sought by Alimera to “clarify the path to regulatory approval”.
Alimera is also currently compiling data regarding controls and specifications regarding the manufacturing, packaging and sterilization of the experimental drug.
The FDA’s CRL also identified deficiencies in cGMP (current good manufacturing practices) in two third-party manufacturers. Alimera says its third-party manufacturers are currently resolving these flaws.
Sources: Alimera, FDA, Bloomberg, and pSdivida Corp.
Christian Nordqvist
Medical News Today