WATERTOWN, Mass. (AP) – Drug delivery product company pSivida Corp. said regulators informed them that they need more data before they can approve a drug it licensed to Alimera Sciences Inc.
The Food and Drug Administration told Alimera that its application for the drug Iluvien cannot be approved in its present form, the companies said. The drug is a treatment for diabetic macular edema, a disease of the retina that affects individuals with diabetes and can lead to blindness.
The FDA wants updated safety and efficacy data on Iluvien as well as further analysis of the data so it can better assess the relative benefits and risks of the drug, the companies said. Alimera has the updated data and is completing the analysis requested, they said. It is also seeking a meeting with the FDA to clarify the path for the drug’s approval.
The FDA did not ask for any new clinical studies, the companies said. Regulators did note “deficiencies in current good manufacturing practices” during inspection of two of Alimera’s third-party manufacturers. The manufacturers are addressing the issues, Alimera said.
Date: December 23, 2010
Source: Associated Press