FDA Delays Approval of Iluvien to Treat Diabetic Macular Edema

January 4, 2011

I wrote a comprehensive report about Iluvien and the status and promise of other sustained release drug delivery systems (Iluvien and the Future of Ophthalmic Drug Delivery Systems). At that time, Alimera Sciences, the company developing Iluvien (under license from pSivida) had filed a new drug application (NDA) to treat diabetic macula edema (DME). The company obtained priority review status for the NDA at the end of August, raising the expectation that an approvable letter might be obtained by the end of 2010.

However, instead of an approvable letter, Alimera Sciences announced in late December that it had received a “complete response letter” (CRL) from the FDA, communicating to the company that its NDA application “cannot be approved in its present form”.

The good news is that the FDA did not request any additional clinical trials, only that it wanted additional data and analysis from the company’s two clinical trials (the FAME study) conducted with Iluvien. The company had submitted 24 month data from the studies in its NDA and the FDA wanted an additional 12 months worth of data, out to month 36. The 36 month FAME study was completed in October, and the company is currently in the process of compiling the data requested by the FDA.

According to data I have seen, based on an analysis of the 30-month results of the FAME Study, the company should have no problem filing the new information with the FDA and eventually receiving its marketing approval – however, probably with a year’s delay.

For the rest of the story, including a look at the 30-month data, please follow this link.




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