FDA Approves Aerie Pharma Intraocular Pressure Drug

FDA has approved an Aerie Pharmaceuticals NDA for Rocklatan (netarsudil and latanoprost) ophthalmic solution, 0.02/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Approval is based on data from two Phase 3 studies, MERCURY 1 and MERCURY 2, with Rocklatan meeting its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, the company says. “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,” it says.

On the safety side, the two studies showed that Rocklatan treatment was associated with generally mild and tolerable ocular adverse events, with minimal systemic side effects, Aerie says. The most common ocular adverse event was conjunctival hyperemia.