Company Seeks Eye Treatment Approval for Fourth Time
Intraocular fluocinoline treats diabetic macular edema (December 19)
Alimera Sciences Inc. has announced that it will try for a fourth time to obtain FDA approval for an eye treatment for diabetes patients. The drug–device combination, Iluvien (fluocinolone acetonide), is a sustained-release eye implant used to treat vision loss associated with chronic diabetic macular edema (DME).
The product was most recently rejected by the FDA in October 2013 because of safety concerns.
In its reply to the FDA’s complete response letter, Alimera intends to address questions that the agency raised regarding the facility at which Iluvien is manufactured. In addition, the company expects to provide a safety update on Iluvien, which will include data from patients’ and physicians’ experiences with the applicator in the U.K. and Germany, where Iluvien is commercially available.
Alimera plans to submit another marketing application in the first quarter of 2014.
Iluvien (190-mcg intravitreal implant in applicator) is a sustained-release intravitreal implant indicated in Europe for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each implant provides a therapeutic effect for up to 36 months by delivering sustained submicrogram levels of fluocinolone acetonide. The implant is injected in the back of the patient’s eye. In a pivotal study, the most common adverse reactions to treatment included the development of cataracts and increased ocular pressure.