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Alimera Sciences Inc. has received a complete response letter (CRL) for the new drug application (NDA) for its sustained-release intravitreal implant, Iluvien, from the FDA.
Atlanta-Alimera Sciences Inc. has received a complete response letter (CRL) for the new drug application (NDA) for its sustained-release intravitreal implant, Iluvien, from the FDA.
Identifying concerns regarding the benefit to risk and safety profiles of the implant, the FDA stated that the NDA could not be approved in its present form.
To address the clinical and statistical deficiencies identified, the FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients.
The FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee might be of assistance in addressing the deficiencies and providing advice whether a patient population can be identified in which the benefits of the drug product might outweigh the risks.
In the CRL, the FDA also referenced deficiencies at the facility where the implant is manufactured, however, Alimera said it does not believe that these issues will affect its European commercial supply.
“The FDA’s decision not to approve (the product) at this time is disappointing not only to us, but also to retinal specialists and diabetic macular edema patients in the United States,” said Dan Myers, president and chief executive officer of Alimera. “But we will continue to work with the FDA, through the advisory committee, to determine whether there is a path forward in the United States for (the technology).”
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