Iluvien NDA on track after further FAME data

Alimera Sciences Inc. (NASDAQ:ALIM) said it remains on track to resubmit an NDA to FDA for Iluvien by the end of the quarter after reporting additional data from the two Phase III FAME trials of the diabetic macular edema product. Iluvien led to significant improvements in the percentage of patients whose best corrected visual acuity (BCVA) improved by at least 15 letters from baseline at months 30 and 33 vs. sham control, with non-significant improvements seen through month 36. Additional data will be presented at the Angiogenesis, Exudation and Degeneration meeting in Miami this month.

Last December, FDA issued a complete response letter for the injectable insert delivering sustained release fluocinolone acetonide (FA) to the retina. FDA did not request any additional clinical trials, but did ask for further analyses of safety and efficacy data through month 36 from the FAME trials. Alimera previously reported that both low- and high-dose Iluvien met the primary endpoint of a significant difference in the percentage of patients whose BCVA improved by at least 15 letters from baseline to 24 months vs. sham control. Alimera has rights to Iluvien from pSivida Corp. (NASDAQ:PSDV; ASX:PVA) under a 2008 deal. ...