Successful Phase III trial of Roclatan (netarsudil/latanoprost ophthalmic solution) to treat glaucoma or ocular hypertension. - Aerie Pharmaceuticals Inc.

Aerie Pharmaceuticals, Inc. 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 (netarsudil/latanoprost ophthalmic solution) to treat glaucoma or ocular hypertension. 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 topline 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 (netarsudil ophthalmic solution) 0.02%, 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 3 mmHg (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 36 mmHg.

Comment: Aerie expects to submit a New Drug Application to the FDA for Roclatan in the first half of 2018, provided that safety results from a 12-month Phase III study set to read out later this year are positive.