FDA approved Rocklatan, a once-daily eye drop produced by Aerie Pharmaceuticals Inc., for patients with open-angle glaucoma or ocular hypertension.
Aerie Pharmaceuticals Inc. announced earlier this week that their once-daily eye drop for patients with open-angle glaucoma or ocular hypertension received approval from the US Food and Drug Administration (FDA).
Rocklatan is a fixed-dose combination of latanoporst, the most widely-prescribed prostaglandin analog, and netarsudil, the active ingredient in Rhopressa, specifically designed to target the trabecular meshwork that Aerie plans to launch in the second quarter of 2019.
“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 chief executive officer at 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.
The once-daily eye drop was approved by the FDA to reduce elevated intraocular pressure (IOP) in patients. The FDA approval is based on data from 2 phase 3 registration trials, MERCURY 1 and MERCURY 2. In these studies, Rocklatan achieved its 90-day efficacy endpoint and positive 12-month safety and efficacy results while demonstrating superior IOP reduction over latanoprost and netarsudil at every measured time point.
More than 60% of patients taking Rocklatan in the 2 studies achieved IOP reduction of 30% or more, which is almost twice the level achieved by participants taking only latanoprost. Nearly twice as many patients using Rocklatan reached a level of 16 mmHg or lower and almost 3 times as many reached 14 mmHg or lower compared to those taking latanoprost.
In the 2 studies, Rocklatan treatment was associated with mild and tolerable ocular adverse events with minimal systemic side effects. The most common adverse event in the controlled studies was conjunctival hyperemia. Of the patients who experienced hyperemia, 90% of them reported it as mild and 5% discontinued because of it. Other adverse effects reported included instillation site pain, corneal verticillata, and conjunctival hemorrhage.