Fluocinolone NDA submitted as DME therapy

Atlanta-Alimera Sciences has submitted a new drug application (NDA) to the FDA for its investigational sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide (Iluvien) for the treatment of diabetic macular edema (DME).

In the submission, the company requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of this year.

“We believe that [fluocinolone], if approved, will provide a needed alternative to the multiple injections of corticosteroids and anti-[vascular endothelial growth factor] therapies used off-label for extended efficacy in DME,” said Dan Myers, president and chief executive officer of Alimera. “We believe this would be the first ophthalmic drug therapy to be approved for DME and the only DME treatment that works in terms of years, not months.”

The company is conducting two phase III pivotal clinical trials (collectively known as the FAME study) of fluocinolone. They involve 956 patients in sites across the United States, Canada, Europe, and India and are assessing the efficacy and safety of fluocinolone with two doses, a high dose and a low dose, for the treatment of DME.

The primary efficacy endpoint for the FAME study is the difference in the percentage of patients in whom best-corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study will conclude later this year, with the final patient visits at the 3-year data point.

The 24-month clinical readout from the study was completed and announced in December. The NDA submission includes the 24-month, low-dose data from the FAME study. The company plans to follow the NDA submission with registration filings in certain European countries and Canada soon.