pSivida’s lead investigational new product is a three-year sustained-release implant containing fluocinolone acetonide , a corticosteroid, in late stage clinical development for the treatment of posterior uveitis. The product utilizes the proven Durasert Technology platform. The first Phase 3 study achieved its primary endpoint with high statistical significance. The second Phase 3 study results are expected first half of 2017. Filing in the EU is anticipated first half of 2017 and second half of 2017 in the U.S.
- pSivida Submits Marketing Authorization Application (MAA) for Approval of Durasertâ„¢ Three-year Treatment for Posterior Segment Uveitis in the European Union
- pSivida’s Durasertâ„¢ Three-year Treatment for Posterior Segment Uveitis Successfully Achieves Primary Efficacy Endpoint in Second Phase 3 Study
- Durasert™ Three-year Treatment for Posterior Segment Uveitis Significantly Reduces Recurrences Through 12 Months