**pSivida Progresses with Iluvien: FDA Resubmission and European Launch Imminent**
pSivida Corp., a leader in sustained release ophthalmic treatments, announced significant progress with their product, Iluvien. Their licensee, Alimera Sciences, Inc., is gearing up for a planned resubmission to the FDA and is preparing for a European launch.
Iluvien is designed to treat diabetic macular edema (DME), a retinal condition that can lead to severe vision impairment. The product employs a tiny, injectable insert that releases the drug fluocinolone acetonide over three years. This sustained release mechanism presents a promising treatment for patients, potentially improving compliance and efficacy.
The initial FDA application for Iluvien raised some concerns, primarily regarding the drug’s safety profile. To address these issues, additional clinical data was required, and pSivida has since been working to gather and evaluate these data points. This upcoming resubmission is expected to incorporate all necessary data that responds to the FDA’s initial concerns. The company is optimistic about a favorable review, given the robustness of the new data set.
Concurrent with FDA activities, preparations for an imminent European launch are in full swing. Iluvien has already received a marketing authorization from several European countries, which represents a substantial market opportunity for pSivida and Alimera Sciences. The regulatory landscapes in Europe often vary, but the obtained authorizations indicate a strong initial reception.
Bi