Alimera Sciences has refiled Iluvien (fluocinolone acetonide) with US regulators in the hope of finally getting its eye implant to patients.
The move marks the fourth time the company has submitted a New Drug Application to the US Food and Drug Administration for Iluvien, after a third rejection last October.
The group is seeking approval for use of Iluvien to treat vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies.
But in the last Complete Response Letter the regulator identified concerns about the benefit to risk and safety profiles of the implant.
The FDA had suggested that a new clinical trial would be needed to address clinical and statistical deficiencies, but the group said it has answered the questions, including providing a safety update.
Iluvien has received marketing authorisations in Austria, the United Kingdom, Portugal, France, Germany and Spain and is commercially available in the United Kingdom and Germany.
