Iluvien is a drug/device combo that slowly disperses drugs into the eye over 36 months. Eligible patients with severe chronic disease will be eligible for 100% cost reimbursements under an FNHA federal program.
"We believe this opinion will help us in our discussions with the [French Economic Committee of Health Products] pricing committee as we work to make Iluvien available to those suffering from chronic diabetic macular edema in France," said Alimera CEO Dan Myers in prepared remarks.
The product is being sold in the U.K. and Germany and has licenses in 6 countries in Europe, but has had trouble getting onto the market in the U.S.
pSivida launched a Phase III U.S. trial this month, following the FDA’s rejection of Iluvien. The study is the 1st of 2 planned efficacy trials to support the eye implant device.