pSivida Corporation announced that its licensee Alimera Sciences has resubmitted its NDA in response to a second Complete Response Letter issued from the FDA for Iluvien for chronic diabetic macular edema (DME).
Alimera’s submission included additional analyses of the risks and benefits of Iluvien based on clinical data available from a previously completed Phase 3 study (FAME). The resubmission focuses on the safety aspects of Iluvien and the population of patients with chronic DME. Alimera does not plan on conducting additional trials for Iluvien for DME at this time.
Iluvien is an extended release intravitreal insert. It is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.
For more information call (617) 926-5000 or visit www.psivida.com.