Eye Treatment Iluvien (Fluocinolone Intravitreal Implant) Tries Again for FDA Approval
Drug–device combo rejected in October 2013
For the fourth time, a new drug application (NDA) for Iluvien (fluocinolone acetonide [FAc] intravitreal implant in an applicator) has been submitted to the FDA for review.
In its resubmission, the product’s developer (Alimera Sciences) responded to questions raised in the agency’s October 2013 complete response letter and provided a safety update, which included commercial experience with Iluvien in Europe.
The FDA had asked for a new trial of the drug–device combination, but Alimera’s partner, Psivida Corp., said that additional studies were not necessary.
The eye implant is intended to treat blindness associated with diabetic macular edema (DME). According to Alimera, treatment provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc.
Iluvien is injected in the back of the patient’s eye to a position that takes advantage of the eye’s fluid dynamics. The applicator employs a 25-gauge needle, which allows a self-sealing wound. In the FAME study, the most common adverse drug reactions included cataract, cataract operation, and increased ocular pressure.