Medidur fluocinolone acetonide intravitreal implant: Phase III data
Top-line data from a double-blind, international Phase III trial in 129 patients with recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis showed that 0.18 mg intravitreal Medidur met the primary endpoint of a lower recurrence rate of posterior uveitis at 6 months vs. sham control (18.4% vs. 78.6%, p<0.00000001). Additionally, 23% of Medidur-treated eyes had a >=15 letter improvement on the Early treatment Diabetic Retinopathy Study (ETDRS) eye chart from baseline to 6 months vs. 4.9% of eyes treated with sham control (p=0.011). Furthermore, 4.6% of Medidur-treated eyes had a >=15 letter reduction on the ETDRS eye chart from baseline to 6 months vs. 31% of eyes treated with sham control (p<0.0001). In 65 patients receiving systemic therapy at baseline, 18.2% of patients receiving Medidur were still being administered systemic treatment at 6 months vs. 52.4% of patients receiving sham control (p<0.01). Additionally, 27.6% of Medidur-treated eyes experienced an increase in intraocular pressure (IOP) to >21 mmHg for >=1 observation vs. 16.7% of eyes treated with sham control. At 6 months, 2.3% of Medidur-treated eyes required an incisional procedure to reduce IOP vs. 0% of control eyes. ...