Alimera Sciences, Inc., (ALIM) said on Monday that its New Drug Application or NDA for Iluvien has been accepted for filing and granted priority review status by the U.S. Food and Drug Administration or FDA.
Iluvien is Alimera's investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema.
Alimera is currently conducting two Phase 3 pivotal clinical trials 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 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.
Following its NDA submission to the FDA, Alimera submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain.
The company expects to file in Canada in September. Based upon the analysis of the FAME Study, all filings include the 24-month low dose data only.
ALIM closed Monday's regular trading at $8.10, down $0.07 or 0.86%. Further, the stock lost $0.04 or 0.49% in the after hours.
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