The two companies are developing the system to treat diabetic macular degeneration. The investigational drug delivery system is designed for sustained release of Iluvien with an intra-vitreal insert.
The FDA said the drug "cannot be approved in its present form," Watertown, Mass.-based pSivida said in a press release.
The FDA wants analyses of safety and efficacy data through month 36 of Alimera’s Fame study. In response, the company requested a meeting with the agency to "clarify the path to regulatory approval." The company is also putting together reports on its manufacturing, packaging and sterilization for Iluvien for the FDA at its request, according to pSivida.
The companies filed the NDA with the FDA in June and won priority review status for Iluvien in August. pSivida and Alimera have also submitted applications for the technology in the United Kingdom, Austria, France, Germany, Italy, Portugal and Spain.