Iluvien Update: FDA Marketing Approval Delayed

Last July, 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 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.

In addition, the FDA requested information concerning controls and specifications related to the manufacturing, packaging, and sterilization of Iluvien. (A hopeful sign.) The FDA also identified shortcomings in good manufacturing practices during inspections of two third-party manufacturing facilities conducted in August and September. According to the company, the third-party manufacturers are working diligently to correct the deficiencies.

Alimera has requested an expedited meeting with the FDA, expected to occur in February, and expects to be prepared to file the requested additional information by the end of the first quarter of 2011.

Based on the data we have seen for results for Iluvien through 30 months, we do not anticipate any problems with the 36 month data requested by the FDA. (See the Graph below.)

From: A presentation on the FAME Study results, by Andrew Pearson MD, Professor Ophthalmology, University of Kentucky, given at the ASRS Meeting, Vancouver, Canada, August 2010.

According to two investment reports that we have seen (from Citigroup and Oppenhiemer – both of which follow the company), the analysts believe that the company will be able to fulfill the FDA’s requests and both expect that the company will obtain marketing approval either in the 4th quarter of 2011, or 1st quarter of 2012, with product launch by early 2012.

About the FAME Study

Alimera conducted two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien with two doses, a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in October 2010 with the final patient visit at the three-year data point.