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Alimera Sciences requests priority review of intravitreal insert for DME
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ATLANTA — Alimera Sciences has submitted a new drug application to the U.S. Food and Drug Administration requesting a priority review of its Iluvien intravitreal insert, the company announced.
If granted priority review, the FDA could issue Alimera an action letter for the diabetic macular edema treatment as early as the fourth quarter, the release said.
Currently, Alimera is undertaking two pivotal phase 3 trials — known as the FAME (Fluocinolone acetonide in diabetic macular edema) clinical program — evaluating the efficacy and safety of Iluvien (sustained release fluocinolone acetonide) among 956 patients with DME at multiple sites across the United States, Canada, Europe and India. Specifically, the program is assessing both high- and low-dose formulations of the drug to determine the percentage of patients whose best corrected visual acuity improved by 15 or more letters at month 24 between treatment and control groups, according to the release.
Alimera's NDA submission includes 24-month low-dose data from the FAME Study.
As previously announced, the company plans to proceed with registration filings in Europe and Canada.
With final patient visits slated for the 36-month data point, Alimera expects to close the FAME clinical program later this year.
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