How Soon Will Iluvien be Available to Treat Diabetic Macular Edema?

September 5, 2010

I recently wrote an extensive article about Illuvien and the future of ophthalmic drug delivery systems.

Illuvien is a new hope in the treatment of diabetic macular edema (DME). Illuvien delivers fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years, thus forgoing the need for multiple drug injections and/or laser treatments to alleviate the symptoms.

Well, Alimera, the company behind Illuvien, received good news yesterday in the form of notification from the FDA that its NDA (new drug application) for Iluvien had been accepted for filing and granted Priority Review status. FDA Priority Review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 months to six months.

With priority review, Alimera could receive a response from the FDA in the fourth quarter regarding its NDA for Iluvien, which was submitted at the end of June 2010.

This is exciting news for patients, and will provide an alternative to laser, frequent injections and off-label treatments currently available for DME.

Here is a link to the full article.




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