Medidur, an injectable insert that provides sustained release of flucinolone acetonide for 3 years, can prevent recurrence of posterior uveitis for 6 months.
pSivida announced in a press release that the insert met its primary efficacy endpoint in a phase 3 clinical trial.
The micro-insert is the same as that used in Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences) for the treatment of diabetic macular edema.
The randomized, multicenter, double-masked clinical trial included 129 patients. At 6 months the recurrence rate of posterior uveitis was significantly reduced in the treatment group, occurring in 18.4% of eyes treated with Medidur and 78.6% of control eyes (P < .00000001).
Additionally, visual acuity improved by 15 letters or more from baseline in 23% of eyes in the Medidur group compared with 4.9% in the control group (P = .011). The number of eyes losing 15 letters or more from baseline was smaller in the treatment group, 4.6% vs. 31% (P < .0001).
Of 65 patients who received systemic therapy at baseline, 52.4% of controls and 18.2% of patients in the Medidur group were still undergoing these therapies at 6 months (P < .01).
IOP was greater than 21 mm Hg in 27.6% of eyes in the Medidur group and 16.7% of controls. Of 64 phakic eyes at baseline, 9.5% of eyes in the Medidur group and 4.8% of controls required cataract surgery. These differences were not statistically significant.
A second phase 3 clinical trial for Medidur will include up to 150 patients at about 15 centers in India. If results of the trial are favorable, pSivida will file a new drug application with the FDA in the first half of 2017.