Uveitis

FDA Accepts Durasert NDA for 3-Year Treatment of Posterior Segment Uveitis

By March 22, 2018

The FDA have set a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018 for Durasert.

NDA Submitted for Durasert 3-Year Implant for Posterior Segment Uveitis

By January 08, 2018

The NDA submission was supported by data from two Phase 3 studies that met the primary efficacy endpoint of prevention of recurrence of uveitis at 6 months of follow-up (P<0.001).

Implant Compared to Systemic Anti-inflammatory Therapy for Treating Uveitis

May 08, 2017

In seven-year follow-up, visual acuity better than with intravitreous fluocinolone acetonide implants