Alimera Sciences has filed a marketing authorisation application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for Iluvien.
Iluvien is a sustained release drug delivery system that release steroid flucocinolone acetonide for the treatment of diabetic macular edema (DME).
A 24 month low dose data from Fame study is said to have been supported the MAA submission.
Iluvien was developed by pSivida and has been licensed to Alimera in 2005.
Prior to MAA submission Alimera has already submitted the NDA with the FDA for Iluvien to treat DME. Alimera is now planning to initiate the registration filing in Canada following MAA submission. pSivida has joint ownership and reference rights to the MAA and NDA.
The MAA is being submitted through the decentralised procedure with the UK MHRA as the reference member state (RMS). Applications have also been submitted to the following other concerned member states (CMS) in the EU: Austria, France, Germany, Italy, Portugal and Spain.