pSivida Corp. (NASDAQ:PSDV), a specialty pharmaceutical company that is a leader in developing sustained release drugs for treatment of back-of-the-eye diseases, today announced that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante) has issued a favorable opinion for the reimbursement and hospital listing by the French National Health Insurance of ILUVIEN® for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and despite optimized management of diabetes. ILUVIEN is licensed to and sold by Alimera Sciences.
In France, patients will be reimbursed for 100% of the cost of ILUVIEN under Affection de Longue Duree, a program for severe chronic disease, such as diabetes. Alimera has reported that it will now move forward with the next step in the process, which is to determine the price and any reimbursement conditions for ILUVIEN in France with the Comite Economique des Produits de Sante or CEPS. Alimera further reported that it believes the CT’s positive opinion for reimbursement of ILUVIEN will help it in its discussions with the CEPS pricing committee.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, Spain and the U.K. and is awaiting authorization in Italy. Alimera has resubmitted the New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis, a chronic back-of-the-eye disease, with the same micro-insert as ILUVIEN for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida's FDA-approved Retisert® licensed to Bausch & Lomb Incorporated provides long-term, sustained drug delivery to treat posterior uveitis.