Roclatan successfully achieves primary efficacy endpoint in Mercury 2 Study

Shares of US eye disease specialist Aerie Pharmaceuticals (Nasdaq: AERI) leapt 27.53% to $51.65 in after-hours trading yesterday, after it reported the successful primary efficacy results of the company’s 90-day Phase III “Mercury 2” registration trial for its fixed-dose combination product candidate, Roclatan, a once-daily eye drop that combines Rhopressa (netarsudil) with latanoprost.

The results of Mercury 2 were consistent with the successful 90-day efficacy results from the Mercury 1 trial, a 12-month Phase III registration trial for Roclatan, which reported top-line efficacy findings in September 2016. Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components, including Aerie product candidate Rhopressa, and market-leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening. The IOP-lowering effect of Roclatan was 1 to 3mmHg (millimeters of mercury) greater than monotherapy with either latanoprost or Rhopressa throughout the duration of the study. The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36mmHg.

Regulatory filing hoped for in first-half 2018