Aerie Pharmaceuticals announced topline efficacy results from a double-masked, randomized, placebo-controlled study designed to evaluate the effect of Rhopressa (netarsudil ophthalmic solution 0.02%) on aqueous humor dynamics in patients with open-angle glaucoma or ocular hypertension. While several preclinical models and a previous study in healthy volunteers examined the effect of Rhopressa on trabecular meshwork outflow facility, this study is the first performed on glaucoma patients to confirm that it lowers IOP primarily through this mechanism.
The study enrolled patients who were diagnosed with open-angle glaucoma or ocular hypertension in both eyes, with unmedicated baseline IOP between 20 and 30 mmHg (millimeters of mercury). The primary endpoint of the study was the mean change from baseline in the mean diurnal outflow facility, measured using previously published methods.1
In the study, Rhopressa produced a statistically significant increase in trabecular outflow facility of approximately 35 percent over baseline. A complete analysis of the study data will be presented at a future scientific congress.
“Elevated IOP in open-angle glaucoma is due to dysfunction of the trabecular outflow pathway. This study confirms that in patients with elevated IOP, Rhopressa lowers IOP by increasing trabecular outflow facility,” Casey C. Kopczynski, PhD, Chief Scientific Officer, Aerie Pharmaceuticals, said in a company news release. “We believe this will give physicians additional confidence that Rhopressa targets the tissue responsible for elevated IOP in their patients, and it will help them understand their options for combining this novel trabecular outflow drug with other therapies that lower IOP through different mechanisms.”
This topline finding is consistent with the published results of a study of similar design in healthy volunteers (AR-13324-CS102; NCT02406287) in which Rhopressa was also shown to exert a statistically significant effect on trabecular outflow facility.1
1 Kazemi A, McLaren JW, Kopczynski CC, Heah TG, Novack GD, Sit AJ. The effects of netarsudil ophthalmic solution on aqueous humor dynamics in a randomized study in humans. J Ocul Pharmacol Ther. 2018 Feb 22. doi: 10.1089/jop.2017.0138.