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The FDA has approved Rocklatan, a once-daily IOP-lowering eye drop for patients with open-angle glaucoma, Aerie Pharmaceuticals announced in a press release this week.
Aerie Pharmaceuticals announced that 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 (PGA), 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 two 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 two MERCURY 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 three times as many reached 14 mmHg or lower compared to latanoprost.
In the two MERCURY 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. Other common ocular adverse effects reported in the studies include instillation site pain, corneal verticillata, and conjunctival hemorrhage (eye redness).
Last reviewed on March 15, 2019