Alimera Sciences submits European marketing application for Iluvien intravitreal insert

ATLANTA — Alimera Sciences has submitted a marketing authorization application to the Medicines and Healthcare Products Regulatory Agency in the U.K. for its Iluvien intravitreal insert for treatment of diabetic macular edema, the company announced in a press release.

With the U.K. named as the reference member state within the European Union, Alimera has also submitted applications to other concerned member states, including Austria, France, Germany, Italy, Portugal and Spain, according to the release.

"This [marketing authorization application] submission closely follows the submission of our NDA to the U.S. Food and Drug Administration last week, and marks an important first step toward the availability of a sustained release treatment for DME patients in Europe," Dan Myers, president and CEO of Alimera, said in the release. "We anticipate that Iluvien, if approved, will be welcomed by physicians and patients alike as a much-needed, long-term alternative to the multiple injections of corticosteroids and anti-VEGF therapies currently used off-label for DME."

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 U.S., Canada, Europe and India. 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.

As with its new drug application submission to the FDA last week, Alimera's marketing authorization application includes the 24-month low-dose data from the FAME Study.

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