Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its recent resubmission of the New Drug Application (NDA) for ILUVIEN@ has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the FDA's November 2011 letter and that a new Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 has been established.
In the resubmission, Alimera responded to questions raised in the FDA's letter and provided additional analyses as well as new information to support that ILUVIEN is safe and effective in the treatment of patients with chronic diabetic macular edema (DME). Using data from Alimera's two previously completed pivotal Phase 3 clinical trials (collectively the FAMET Study), the resubmission focused on the safety aspects of ILUVIEN and the subgroup population of patients with chronic DME, the same subgroup for which marketing approval for ILUVIEN has been granted in six countries in the European Union. Additionally, data was submitted from the completed physician utilization study for the ILUVIEN applicator and from a special reading center assessment of photographs of the fundus, or interior surface of the eye, which were collected during the FAMET Study.
At month 36, the treatment effect for the chronic DME subgroup (i.e. the difference in the proportion of 15 Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart letter responders between ILUVIEN and the sham control) was more than twice that seen for the overall population. Given that the risks associated with the chronic DME subgroup are similar to the risks in the overall population, Alimera believes that the benefit to risk for this subgroup is optimized with ILUVIEN treatment.
"We believe this FDA resubmission package includes important new information that demonstrates the safety and efficacy of ILUVIEN for patients suffering from chronic DME," said Dan Myers, Alimera's president and chief executive officer. "We believe a clearer positioning now exists for ILUVIEN in the treatment of patients with chronic DME, since a first line pharmacotherapy for DME was approved by the FDA last year. We look forward to the FDA's response to our New Drug Application. In the meantime, we continue to move forward with our ILUVIEN commercial launch plans in Europe."