Aerie Reports Top-line Results From Phase 1 AR-13324 PK Study - Quick Facts

(RTTNews) - Aerie Pharmaceuticals, Inc. (AERI) announced top-line results from its Phase 1 pharmacokinetics (PK) study, in which AR-13324 eye drops were administered once-daily to 18 healthy individuals over an eight-day period to assess systemic exposure to the drug. The company reported that the PK results demonstrated very low systemic exposure to the drug, with blood levels at or below the limit of detection of 0.1 ng/mL at all time points. There were no drug-related effects on systemic safety parameters such as blood pressure and heart rate. After eight days of dosing, once-daily administration of AR-13324 reduced the average diurnal intraocular pressure to approximately 11 mmHg, representing a decrease of approximately 5 mmHg, or over 30 percent.

Aerie plans to commence two Phase 3 registration trials of AR-13324 in mid-2014, with total expected enrollment of approximately 1,200 patients. Aerie expects to submit an NDA filing for AR-13324 by mid-2016.