ISTA Pharmaceuticals has initiated a Phase III clinical programme for Remura, a bromfenac ophthalmic solution to relieve the symptoms of dry eye disease.
The four double-blind, randomised and placebo-controlled studies are designed to evaluate Remura’s safety and efficacy. They being conducted under special protocol assessment agreements with the US Food and Drug Administration (FDA).
Two Phase III studies have already been initiated and will assess the efficacy and safety of bromfenac in about 1,000 patients with mild to moderate dry eye disease.
The patients will receive a placebo or two concentrations of bromfenac, and will be randomised at a ratio of 1:1:1 to receive bromfenac or placebo in both eyes, twice a day, for a period of 42 days.
For both the studies, the Lissamine Green test will be used for measuring the objective sign of conjunctival staining and the ocular surface disease index will be used to measure subjective symptoms.
The studies will be conducted across 30 sites in the US, and the results are expected in the middle of 2011.
The remaining two Phase III studies of Remura would be dependent upon the additional special protocol assessments currently under evaluation by the FDA.
