pSivida announced the submission of its New Drug Application (NDA) for Durasert (fluocinolone acetonide) 3-year treatment to the Food and Drug Administration (FDA) for posterior segment uveitis.
Posterior segment uveitis is a chronic inflammatory disease that typically involves the retina. Durasert is micro-insert implant administered as a single intravitreal injection given in an office-based setting; the technology allows for sustained-release drug delivery of small molecules.
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). In one study (n=153), 21.8% of Durasert-treated patients had a recurrence vs 53.8% in the sham group. In addition, 12-month follow-up data in another study showed a significant reduction in recurrence with Durasert vs sham (27.6% vs 85.7%).
Regarding safety, study patients treated with Durasert 3-year posterior segment uveitis treatment demonstrated a consistent profile with that of standard of care steroid treatments for this condition.
For more information call (617) 926-5000 or visit pSivida.com.