The US Food and Drug Administration (FDA) was unable to approve Iluvien (fluocinolone acetonide, Alimera Sciences) without more data to support that Iluvien is safe and effective for the treatment diabetic macular edema (DME), according to the drug’s manufacturer. The FDA stated that the risks of adverse reactions shown for Iluvien in the FAME study were significant and were not offset by the benefits demonstrated by Iluvien in these clinical trials, according to an Alimera news release.
In a Complete Response Letter (CRL), the FDA indicated that Alimera will need to conduct 2 additional clinical trials to demonstrate that the product is safe and effective for the proposed indication. A CRL is a letter issued by the FDA when the FDA staff have finished reviewing all of the experimental and other data in a new drug application and there are outstanding questions that prevent approval of a drug.
“Overall, we were surprised and disappointed with the FDA’s decision on our application to market Iluvien in the US to patients with this devastating disease,” Dan Myers, President and Chief Executive Officer of Alimera, said during a conference call with investors. “Based on our extensive research with US retinal physicians, we have learned that Illuvien’s long-term sustained delivery treatment benefit is desired, and that Illuvien has a manageable benefit-to-risk ratio.”
When asked if Alimera plans to move forward with the 2 additional trials required by the FDA, Mr. Myers expressed doubt.
“Two replicable trials, the size of the FAME trial, and the same cost of those trials, would not be feasible for us to pursue, especially considering that the endpoints as we dealt with before continue to be somewhat nebulous.… I think we would probably look for other opportunities— maybe in the back of the eye for Illuvien with other indications we have the rights to,” Mr. Myers said.
Alimera said it has requested a meeting with the FDA to clarify the next steps.
“The FDA decision was very disappointing. For patients with diffuse DME, a device such as Iluvien was their best chance of having sustained maintenance,” said David M. Brown, MD, the director of the Greater Houston Retina Research Center and a retina specialist from Retina Consultants of Houston, said in an interview with Retina Today. “It’s heartbreaking that the patients can’t make a decision with the doctor about a risk-benefit ratio given the data that exist.”
In December 2010, the FDA issued a CRL to Alimera regarding its new drug application for Iluvien in the treatment of DME, which included data through month 24 of the FAME Study. Alimera submitted a response to the FDA in May 2011, addressing issues raised in the letter, including 36-month trial data.
In Europe, Alimera will submit its formal response to the Preliminary Assessment Report to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is expected to make a recommendation on the approvability of Iluvien to Alimera and the Concerned Member States (Austria, France, Germany, Italy, Portugal, and Spain) by the end of the year, with a decision on the approval of Iluvien expected in the first half of 2012.
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