Alimera, FDA enter labeling discussions regarding Iluvien
Alimera Sciences and the U.S. Food and Drug Administration have begun discussing labeling for the Iluvien implant, and as a result, the company is not required to participate in the Dermatologic and Ophthalmic Drugs Advisory Committee meeting scheduled for Jan. 27.
According to a press release from Alimera, the company will draft a response to a complete response letter it received from the FDA in October and submit it in the first quarter of 2014.
Alimera intends to address concerns the FDA raised regarding the facility where Iluvien (sustained-release fluocinolone acetonide) is manufactured and draft a safety update on Iluvien with data from the United Kingdom and Germany, where the implant is approved and commercially available, the release said.
The FDA also informed Alimera that it will not be required to conduct new clinical trials for the Iluvien implant, the release said.
“We are very pleased to have had the opportunity to meet with the FDA to discuss appropriate labeling for Iluvien and to determine the next steps required to move Iluvien closer to an FDA approval,” Dan Myers, president and CEO of Alimera, said in the release.
Iluvien is scheduled to launch in France in 2014. It is also approved in Austria, Portugal and Spain and has been recommended for approval in Italy, the release said.