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Alimera resubmits Iluvien for FDA approval

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PSivida Corp. reported that its licensee, Alimera Sciences Inc., resubmitted its new drug application to the U.S. Food and Drug Administration for Iluvien for the treatment of chronic diabetic macular edema.

Alimera owns the global license to manufacture and sell pSivida’s sustained-release intravitreal implant, which delivers submicrogram levels of fluocinolone acetonide for up to 36 months.

Alimera responded to the second Complete Response Letter from the FDA with “additional analyses of the risks and benefits of Iluvien based on the clinical data available from the previously completed phase 3 FAME studies,” according to the pSivida press release.

“The resubmission focuses on the safety aspects of Iluvien and the population of patients with chronic DME,” Alimera said in the release.

“To date, we have received over $30 million from Alimera from its license of Iluvien for DME,” Paul Ashton, PhD, president and chief executive officer of pSivida Corp., said in the release. “If the FDA approves Iluvien, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”