FDA, Alimera enter into Iluvien labeling discussions

Atlanta-Alimera Sciences Inc. has entered into labeling discussions with the FDA for its sustained-release intravitreal implant (Iluvien), and as a result, has reached an agreement that the company’s participation in the 2014 Dermatologic and Ophthalmic Advisory Committee is no longer necessary.

Alimera will instead focus on drafting its response to the complete response letter (CRL) it received from the FDA in October, with a goal of submitting the response during the first quarter of 2014.

In its response, the company intends to address concerns the FDA raised regarding the facility at which Iluvien is manufactured.

Alimera also expects to provide a safety update on the implant, which will include data from Iluvien patients and from physician experience with the applicator in the United Kingdom and Germany, where it is currently commercially available.

The FDA has indicated that Alimera will not be required to conduct any new clinical trials in connection with its review of the implant prior to its approval.

“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 (it) closer to an FDA approval,” said Dan Myers, president and chief executive officer of Alimera. “We are committed to addressing the remaining issues that were raised in the CRL.”

For more articles in this issue of Ophthalmology Times eReport, click here.

To receive weekly clinical news and updates in ophthalmology, subscribe to the Ophthalmology Times eReport.