Glaucoma drug candidate shows low systemic exposure, IOP reduction
Top-line results from a phase 1 pharmacokinetics study showed that a glaucoma drug being developed by Aerie Pharmaceuticals seems to have a low systemic exposure, a high safety profile and an effective IOP-lowering capability, according to a press release.
The drug, AR-13324, was administered as an eye drop to 18 healthy subjects once daily for 8 days. Blood levels after administration were at or below the limit of detection at all time points, and no drug-related effects on systemic safety parameters were observed, according to the release.
Before dosing, all subjects had normotensive IOPs ranging from 12 mm Hg to 21 mm Hg, with a mean diurnal IOP of approximately 16 mm Hg. After 8 days of dosing, mean diurnal IOP dropped to 11 mm Hg, a more than 30% reduction, the release said.
The completion of this study paves the way for two planned phase 3 registration studies of AR-13324, which are expected to begin by mid-year.