Aerie's Roclatan meets in second Phase III for IOP

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) reported top-line data from the Phase III Mercury 2 trial in 750 patients with open-angle glaucoma or ocular hypertension with a baseline intraocular pressure (IOP) of >20 to <36 mmHg showing that once-daily Roclatan netarsudil/latanoprost (PG324) eye drops given in the evening met the primary endpoint of a lower mean IOP at 9 measured time points vs. each of Roclatan’s components -- Aerie’s Rhopressa netarsudil 0.02% and latanoprost 0.005% eye drops. Specifically, Roclatan lowered mean IOP by 2.2-3.3 mmHg over Rhopressa (p<0.0001 for all) and by 1.5-2.4 mmHg over latanoprost (p<0.0001 for all). IOP was measured at 8 a.m., 10 a.m. and 4 p.m. at week 2, week 6 and day 90.

Additionally, 27% of patients receiving Roclatan achieved a ≥40% reduction in IOP at day 90 vs. 5% for Rhopressa and 8% for latanoprost (p<0.0001 for both). Furthermore, 56% of patients receiving Roclatan achieved a mean diurnal IOP of ≤16 mmHg at day 90 vs. 25% for Rhopressa and 36% for latanoprost (p<0.0001 for both). The most common adverse event reported was hyperemia. No treatment-related serious adverse events were reported...