FDA Approves Aerie’s Rocklatan IOP-Lowering Combination

■ The FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution 0.02%/0.005%; Aerie Pharmaceuticals) to reduce elevated IOP in patients with open-angle glaucoma or ocular hypertension. Rocklatan is a once-daily eye drop that is a fixed-dose combination of latanoprost and netarsudil, the active ingredient in Rhopressa (netarsudil ophthalmic solution 0.02%), a first-in-class Rho kinase inhibitor specifically designed to target the trabecular meshwork. Netarsudil works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway. Aerie launched Rhopressa in the United States in April 2018 and launched Rocklatan in the United States in May 2019.

The FDA approval of Rocklatan is based on data from 2 phase 3 registration trials, MERCURY 1 and MERCURY 2. In these studies, Rocklatan achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured time point.

More than 60% of patients taking Rocklatan in the 2 studies achieved an IOP reduction of 30% or more, nearly twice that achieved by participants taking latanoprost alone. Nearly twice as many patients taking Rocklatan reached 16 mmHg or lower and nearly 3 times as many reached 14 mmHg or lower compared to latanoprost.

The most common adverse event was conjunctival hyperemia. Ninety percent of patients who experienced hyperemia reported it as mild and 5% discontinued because of it.