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# FDA Accepts pSivida NDA for Durasert
- URL: https://www.fdaweb.com/fda-accepts-psivida-nda-for-durasert/
- Published: 2018-03-19T12:00:00.000Z
- Updated: 2026-09-14T23:53:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141013

FDA has accepted a pSivida Corp. NDA for Durasert three-year treatment for posterior segment uveitis. The agency has set a user fee review action target date of 11/5\. The submission includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months. In addition, thethe company says the drug’s safety profile was consistent with the safety profile of steroid treatments that are currently considered standard of care for the disease.