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FDA Approves Rocklatan IOP-Lowering Combination

Approval was based on data from the phase 3 MERCURY 1 and MERCURY 2 trials.

Aerie Pharmaceuticals said the FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% 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, the most widely prescribed prostaglandin analog, and netarsudil, the active ingredient in Rhopressa (netarsudil ophthalmic solution) 0.02%, a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork.

The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension. Rhopressa 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. The company plans to launch Rocklatan in the United States in the second quarter of 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, a frequency that was nearly twice that achieved by participants taking latanoprost alone. Rocklatan also helped more patients get to low target pressures. 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.

In the 2 studies, Rocklatan treatment was associated with generally mild and tolerable ocular adverse events, with minimal systemic side effects. The most common ocular adverse event in controlled clinical studies with Rocklatan was conjunctival hyperemia. Ninety percent of patients who experienced hyperemia reported it as mild and 5% discontinued because of it. 

“We are in the unique position of receiving FDA approval on a second glaucoma treatment less than a year from the US launch of Rhopressa,” said Vicente Anido, Jr., PhD, chairman and CEO of Aerie. “Together, Rocklatan and Rhopressa give us a broad therapeutic franchise, based on our ROCK inhibitor netarsudil, that addresses many of the needs of clinicians and patients in a wide variety of treatment settings.”