JUL 29, 2016
One-year data from a phase 3 trial for pSivida’s sustained-release corticosteroid implant (Medidur) shows it is highly effective in preventing recurrence of posterior uveitis.
Medidur is designed to release 0.18 mg of corticosteroid fluocinolone acetonide at a controlled rate for up to 3 years.
Patients in the multi-center study were randomized to receive an injection of Medidur or sham, with the primary endpoint of no uveitis recurrence at 6 months. At 12 months, 26.4% of treated patients experienced recurrence compared with 85.7% of controls (P<0.00000001).
"The continued high efficacy and favorable safety results of Medidur in the treatment of posterior uveitis are impressive,” said principal investigator Glenn Jaffe, MD. “Particularly encouraging is the effectiveness of Medidur in controlling recurrence of disease over the longer 12-month period. Medidur-treated eyes were over 5.2 times more likely to be free of recurrence through 12 months than control eyes."
Additionally, visual acuity improved by 15 or more letters in 22.9% of treated eyes compared with 11.9% of controls at 6 months, with vision maintained at 12 months. Of the patients who required systemic corticosteroids at baseline, approximately 80% of treated patients were medication free at 12 months compared with 50% of controls.
The treatment was also well-tolerated throughout the follow-up period, which ranged from 12 to 30 months (mean of 18). IOP increased mildly in treated eyes, with a 12-month average value 0.6 mm Hg higher than control eyes (1.3 mm Hg and 0.7 mm Hg, respectively), and the percentage of cases requiring glaucoma surgery were not significantly different between the 2 groups.
Patients from the phase 3 trial will continue to be evaluated in 6 month intervals until the 3-year mark.