Aerie Pharmaceuticals’ fixed-dose combination of netarsudil and latanoprost has been cleared by the FDA.
The once-daily drop, Rocklatan, contains the prostaglandin analog latanoprost (0.005%) and the Rho kinase (ROCK) inhibitor netarsudil (0.02%), which is the active ingredient in Rhopressa. Data from a pair of late-stage clinical trials show that Rocklatan lowers IOP more effectively than either of its components.
“We are in the unique position of receiving FDA approval on a second glaucoma treatment less than a year from the U.S. launch of Rhopressa,” said Vicente Anido Jr., PhD, chairman and CEO 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.”
Aerie’s multicenter phase 3 trials, MERCURY 1 and MERCURY 2, randomized patients with open-angle glaucoma or ocular hypertension to receive Rocklatan, netarsudil or latanoprost. In both studies, Rocklatan achieved its primary 90-day efficacy endpoint, demonstrating superior IOP reduction over latanoprost and netarsudil at every time point. More than 60% of patients taking Rocklatan achieved an IOP reduction of 30% or more, nearly twice that achieved by latanoprost alone. Additionally, compared with the latanoprost arm, nearly twice as many patients in the Rocklatan arm reached an IOP of 16 mmHg or lower and nearly 3 times as many reached 14 mmHg.
According to the press release, ocular adverse events were generally mild and tolerable, with minimal systemic side effects. The most common ocular adverse event associated with Rocklatan was conjunctival hyperemia. Although the company did not disclose the percentage of trial participants that experienced conjunctival redness, they noted that most cases were deemed mild and 5% of participants discontinued the trial because of it. Other common ocular adverse events were instillation site pain, corneal verticillata and conjunctival hemorrhage.
Aerie plans to launch Rocklatan (previously known as Roclatan) in the United States in the second quarter of 2019.