Aerie Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved Rocklatan to reduce intraocular pressure, or fluid pressure in the eye, in patients with open-angle glaucoma or ocular hypertension.
Patients with ocular hypertension, or elevated pressure in the eye, are at increased risk to develop glaucoma, a disease which can lead to vision loss and blindness.
Rocklatan eye drops are a fixed-dose combination of Aerie's Rhopressa, or netarsudil, and latanoprost, sold by Pfizer Inc. as Xalatan.
Aerie, which launched Rhopressa in the U.S. in April 2018, plans to launch Rocklatan in the U.S. in the second quarter of 2019.
The FDA approval of Rocklatan is based on results from two phase 3 studies, called Mercury 1 and 2, in which the drug achieved its main goal and showed statistical superiority at reducing intraocular pressure compared to latanoprost and netarsudil.
Aerie CEO and Chairman Vicente Anido said during the company's fourth-quarter earnings call that "at some point" Rocklatan is expected to become the company's top product.
The Durham, N.C.-based pharmaceutical company is planning to file for Rocklatan's approval in Europe, where it will be called Roclanda. Aerie is expecting results from an ongoing phase 3 study in Europe by the end of 2019.
Aerie develops therapies to treat glaucoma, retinal diseases and other diseases of the eye.