JUN 20, 2017
pSivida announced in a press release that their injectable corticosteroid insert (Durasert) met its primary efficacy endpoint in a second phase 3 clinical trial for treatment of posterior uveitis.
Designed to last for up to 3 years, the sustained-release fluocinolone acetonide implant is only 3.5 mm in length and 0.37 mm in diameter, and can be administered through a 25- or 27-gauge needle in an office setting.
This additional randomized, double-masked phase 3 study evaluated prevention of disease recurrence after 6 months in a cohort of 153 patients with posterior uveitis patients. Those treated with the implant demonstrated a significant reduction in the recurrence of disease through 6 months compared with the sham group (21.8% vs. 53.8%, P<0.001). Though positive, these findings are less convincing than the results from their first phase 3 study, in which recurrence after 6 months was observed in 18.4% of treated eyes and 78.6% of control eyes (P<0.00000001).
Both trials are still ongoing, and will follow patients for 3 years.
"Chronic posterior uveitis is challenging to treat as the disease tends to wax and wane over time. Durasert three-year insert is a single-injection, office-based treatment that can last 2-3 years. Therefore, it addresses the need to help prevent recurrences over an extended time period, rather than to treat them episodically, and may represent an exciting new approach to manage these patients," said Glenn J. Jaffe, MD, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine.
To date, 3 products utilizing pSivida’s housing technology have been approved by the FDA to treat ocular diseases in the posterior segment, all of which have been licensed to either Alimera Sciences (Iluvien) or Bausch & Lomb (Retisert and Vitrasert).