Around 300 patients with glaucoma or ocular hypertension will be enrolled in the 28-day trial, who will compare two concentrations of PG324 to latanoprost and to AR-13324, all dosed once daily.
Efficacy endpoint in the trial will be superiority of PG324 to each of its components, as measured by the lowering of mean diurnal intraocular pressure (IOP) on day 28 compared to baseline.
The company said that top-line results of the Phase IIb trial are expected to be released in mid-2014.
Aerie chief medical officer Brian Levy said the company’s Phase IIb trial of PG324 is based on substantial and compelling results it has achieved with its lead candidate, AR-13324, as well as preclinical proof of concept studies for PG324.
"In addition to our recent positive AR-13324 Phase 1 findings, including reductions in IOP in individuals who are normotensive, previous Phase 2b testing of AR-13324 demonstrated significant IOP lowering in the range of 5.7 to 6.2 mmHg in patients with elevated IOP, with consistent IOP lowering across all baseline IOPs tested in the clinical study," Levy said.
"We believe that adding latanoprost to AR-13324 in our fixed-combination product has the potential to provide for maximal IOP lowering in patients with glaucoma and ocular hypertension, by targeting all currently known mechanisms of action that affect intraocular pressure."
The company believes that if PG324 is approved, it would be the first glaucoma product to lower IOP through potentially four mechanisms of action increasing fluid outflow through the trabecular pathway or primary drain, increasing fluid outflow through the uveoscleral pathway or secondary drain, reducing fluid production in the eye and potentially also lowering episcleral venous pressure.
If approved, PG324 is also expected to cover the full spectrum of these IOP-lowering mechanisms, thereby providing a greater IOP-lowering effect than any currently approved glaucoma product.