pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported a number of updates with respect to ILUVIEN® for chronic diabetic macular edema (DME).
Alimera announced that it intends to resubmit its New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of March 2013. Using data from Alimera’s two previously completed pivotal Phase III clinical trials (FAME™ Study), the resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME considered insufficiently responsive to available therapies, the same group for which marketing approval for ILUVIEN has been granted in various EU countries, according to Alimera. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera.
Alimera also announced that shipments of ILUVIEN to the German market are expected to begin in the second quarter of 2013 upon acceptance from the Medicine and Health products Regulatory Agency of the intended commercial batch size, a delay from Alimera’s previous expectation that this would occur in the first quarter of 2013. Alimera further reported that it also expects to begin shipments to the U.K. in the second quarter of 2013 for treatment of privately insured patients.
Alimera reported the submission of a patient access scheme (PAS) for ILUVIEN for DME has been agreed to by the UK’s Department of Health and is now under consideration by NICE for inclusion in its rapid review facility. NICE had previously issued final guidance that ILUVIEN is not a cost-effective treatment for chronic DME considered insufficiently responsive to available therapies. Alimera reported that under the review facility, NICE is expected to assess the impact of the PAS on ILUVIEN’s cost effectiveness and determine whether an update to the final guidance is warranted.