PSDV
Alimera Files for EMEA Approval in Diabetic Macular Edema
Following a recent NDA application for the diabetic macular edema (DME) drug Iluvien, Alimera Sciences (ALIM) also submitted a Marketing Authorization Application (MAA) to the EMEA for the same drug.
The filing for Iluvien, which was licensed to Alimera from pSivida Corp. (PSDV), includes data from the 24-month low dose phase III study known as FAME.
The FAME study is ongoing and will be completed later this year.
DME involves swelling of the retina due to fluid leaking from blood vessels in the eye.
For diabetics, there is only about a 10% lifetime risk of developing the disease, but treatment for the disease involves monthly eye injections that are either costly (Lucentis), unproven (Avastin), or generally avoided (corticosteroids). Iluvien, in comparison, is an injection that has a sustained-release drug delivery system of fluocinolone that can last for years with data on its three-year efficacy coming later this year.
Iluvien took the correct path in entering the ever-growing, multi-billion dollar DME market. With the efficacy of Roche’s Avastin and Lucentis already being quite tough to improve upon and with Avastin poaching sales from Lucentis due its significantly decreased price,
creating a product that will last for years as opposed to months is a by far the best method of entry.
Using this approval as a springboard, Alimera can begin to move into other ophthalmic markets currently owned by Roche and develop Iluvien into a multi-billion dollar drug.
biosmash.com
CRACKER |
