Alimera submits Iluvien NDA for DME to FDA

Jun 29 2010

Alimera Sciences, Inc., (Nasdaq:ALIM), ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME). In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of 2010.

"This is a significant milestone for all of us at Alimera, and represents a major advance toward a rapid and sustained visual acuity benefit for DME sufferers," said Dan Myers, president and CEO of Alimera, adding, "We believe that Iluvien®, if approved, will provide a needed alternative to the multiple injections of corticosteroids and anti-VEGF therapies used off-label for extended efficacy in DME. 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."

Alimera is currently conducting 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 is the difference in the percentage of patients whose 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 three-year data point. The 24-month clinical readout from the study was completed and announced in December 2009.

This NDA submission includes the 24-month low dose data from the FAME Study. Alimera plans to follow this NDA submission with registration filings in certain European countries and Canada in the near future.

SOURCE Alimera Sciences, Inc.