Aerie is developing two glaucoma drugs with multiple MOA in a single medication. The most advanced candidate, Rhopressa, hits IOP from three different angles. Look for release of phase III data by mid-2015 and an NDA by mid-2016. A follow-on product, Roclatan, adds latanoprost to Rhopressa for four distinct MOA.
Rhopressa inhibits rho kinase inhibitors (RKIs) to increase outflow through the trabecular meshwork, said President and CEO Thomas Mitro. The compound also inhibits norepinephrine transport (NET) to decrease aqueous production and lowers episcleral venous pressure.
Phase II trials showed an IOP-lowering effect similar to that of latanoprost. Mean IOP reductions were - 6.2 mm Hg on day 14 and - 5.7 mm Hg on day 28. A key distinction is that while latanoprost loses about 1 mm Hg in efficacy over 4 weeks, Rhopressa maintains a consistent effect, Mitro added.
The phase III trial program that Aerie hopes will move Rhopressa from candidate to approval is a 90-day, non-inferiority trial versus timolol. Multiple studies will include about 1,300 patients, including at least 100 patients with 12 months of safety data needed for the NDA filing. The trial design also calls for an additional 300 patients with six months safety data needed for an EMA filing.
Aerie’s development program for Roclatan is about 12 months behind Rhopressa. A phase IIb trial that pitted two concentrations of Roclatan against both Rhopressa and latanoprost showed superiority over both components at all time points over 30 days.
The most common adverse event was hyperemia. About 80% of hyperemia was rated as mild by biomicroscopy.
“Roclatan is a very good drug for the reduction of IOP compared to current standards of care,” Mitro said. “We are looking forward to launching phase III trials by the middle of this year.”