Since my last update in April (Update 6
), when the first country, Austria, of an anticipated seven European Union country market approvals was announced, four additional EU approvals have occurred, bringing the total of approvals to five – with Austria, France, Portugal, Germany, along with the United Kingdom. Only Italy and Spain remain of the original seven EU countries where approvals were expected.
As I first reported back in November 2011 (Update 4
), the FDA had turned down Alimera’s resubmitted NDA application for approval, stating that questions remained based on the data previously submitted, about the adverse effects (basically a higher risk of cataract formation and raised intraocular pressures) and that these were not offset by the benefits demonstrated (basically up to three years of relief of the symptoms of diabetic macular edema) and that Alimera would have to conduct further tests to prove that its product was safe and effective for the proposed indication.
I thought that this was the end of the line for possible approval in the United States. But, apparently, I have been proven wrong.
I learned today, in a news release
from pSivida, Alimera’s licensor, that Alimera Sciences has indicated its intention to resubmit its application for Iluvien for diabetic macular edema (DME) to the FDA.
Based on a recent meeting with the FDA, Alimera intends to use data from Alimera's two previously completed pivotal Phase III clinical trials (FAME Study).
pSivida expects the resubmission to address the issues raised by the FDA in its November 2011 Complete Response Letter (CRL) and in its recent meeting with Alimera.
pSivida anticipates the resubmission will focus on the population of patients with chronic DME considered insufficiently responsive to available therapies, the same indication for which regulatory approval for Iluvien has been granted in various EU countries. Alimera has not reported an expected time for resubmission.
"We are very pleased at this development in the U.S. in addition to the recent marketing authorizations in Austria, France, Germany, Portugal and the U.K.," said Dr. Paul Ashton, President and CEO of pSivida.
Under a collaboration agreement with Alimera, pSivida granted Alimera an exclusive worldwide license to manufacture and sell Iluvien for the treatment and prevention of eye diseases in humans other than uveitis. Alimera agreed to fund all development costs, pay pSivida a $25 million milestone payment upon FDA approval of Iluvien and 20% of any net profits, as defined, on sales of Iluvien by Alimera.
Stay tuned for any further developments.
Editor’s Note: There is an excellent discussion about the FDA’s turndown of Alimera Sciences’ application to approve Iluvien last November in the current (July/August) issue of Retina Today. This is timely, especially in light of Alimera’s decision to re-file their application, this time for chronic DME.
Three noted retinal specialists, Robert L. Avery, MD; David M. Brown, MD; and Baruch D. Kuppermann, MD, PhD, provide their perspectives regarding Iluvien.
To read their views, please follow this link.