FDA requests more data for DME insert NDA from Alimera

Atlanta-The FDA has requested additional information to aid in its decision of whether to approve a new drug application (NDA) for an investigational fluocinolone acetonide intravitreal insert (Iluvien, Alimera Sciences) for the treatment of diabetic macular edema (DME).

The company submitted the NDA for the sustained drug-delivery system in June; it included safety and efficacy data through month 24 of the FAME Study. The FDA granted the NDA priority review status in August.

The FDA has requested:

• Analyses of the safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted to the FDA, to assess further the relative benefits and risks of the drug.

• Additional information regarding controls and specifications related to the manufacturing, packaging, and sterilization of the insert.

The company has indicated that it is preparing the requested information.

The FDA also indicated that it had observed deficiencies in current good manufacturing practices (cGMP) at two of the company’s third-party manufacturers during facility inspections completed in August and September and that all facilities and controls will need to comply with cGMP. The third-party manufacturers are in the process of resolving those deficiencies, according to the company.

“We appreciate the FDA’s efforts to complete a priority review of our NDA and look forward to working closely with the FDA toward approval of [the insert] for the treatment of DME,” said Dan Myers, president and chief executive officer of Alimera. “To expedite the process, we have requested a meeting with the FDA to clarify the path to regulatory approval.”