**Title: pSivida & Alimera Resubmit NDA for Iluvien to FDA for Diabetic Macular Edema**
pSivida Corp., a specialist in sustained release ophthalmic drug treatments, has announced that its partner, Alimera Sciences, Inc., submitted a resubmission of the New Drug Application (NDA) for Iluvien to the FDA. Iluvien is aimed at treating patients with chronic diabetic macular edema (DME) who have not responded adequately to other therapies.
**Background**: The FDA previously requested additional information to further evaluate the safety and efficacy of Iluvien. Resubmissions can often involve providing new clinical data, additional analysis, or address specific regulatory concerns.
**Key Details**:
– **Submittal Date**: The application includes responses to questions posed by the FDA. It is a resubmission following an initial request for more data.
– **Intended Use**: Iluvien is proposed for patients with chronic DME, a condition where there’s fluid build-up in the retina, leading to vision impairment associated with diabetes.
– **Regulatory Pathway**: The resubmission follows pSivida’s strategy of leveraging partnerships to navigate complex regulatory pathways and bring sustained-release technologies to the market.
**What’s Next?**: The FDA will review the resubmission to determine if Iluvien meets the necessary safety and efficacy benchmarks for approval. This assessment may include a detailed review of any additional