FDA Rejects Eye Implant Device for Third Time
Agency requests more clinical data (October 18)
For the third time, the FDA has rejected Iluvien (Alimera Sciences), an eye implant device, because of safety concerns.
Iluvien (190-mcg intravitreal implant in applicator) is a sustained-release intravitreal implant used to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Each implant delivers sub-microgram levels of fluocinolone acetonide. Iluvien is injected in the back of the patient’s eye with a 25-gauge needle.
Identifying concerns regarding the risk-benefit and safety profiles of Iluvien, the FDA stated in its Complete Response Letter (CRL) that the product’s new drug application could not be approved in its present form. To address the clinical and statistical deficiencies identified, the FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients.
In its CRL, the FDA also referenced deficiencies at the facility where Iluvien is manufactured.
Iluvien is approved and commercially available in the U.K. and Germany and is slated to launch in France early next year.Sources: Alimera Sciences; October 18, 2013; and Reuters; October 18, 2013.