A Japanese phase 2 clinical study of netarsudil ophthalmic solution showed a significant reduction in mean intraocular pressure compared with placebo, Aerie Pharmaceuticals announced in a press release.
The 28-day study evaluated the safety and efficacy of three netarsudil concentrations of 0.01%, 0.02% and 0.04% in 215 subjects with open-angle glaucoma or ocular hypertension. Two hundred and seven subjects completed the study.
A mean diurnal IOP reduction between 4.1 mm Hg and 4.6 mm Hg was recorded in patients treated with the 0.01% concentration. In the 0.02% concentration arm, mean diurnal IOP reduction was between 4.4 mm Hg and 4.8 mm Hg, and in the 0.04% concentration arm, mean reduction ranged between 4.8 mm Hg and 5.1 mm Hg. All three concentrations were statistically significantly greater reductions than achieved with placebo (all P < .0001).
A Rho kinase inhibitor, netarsudil ophthalmic solution 0.02% is known as Rhopressa in the United States, where it is approved for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.
“These results from our Japanese phase 2 study are important from several perspectives. Of course, they point to the strong potential for Rhopressa in Japan, which is the third largest glaucoma market in the world. These data also highlight the potential of Rhopressa for the large population of glaucoma patients who suffer from normal-tension glaucoma, essentially those patients with lower pressures that still suffer from the disease,” Aerie Chairman and CEO Vicente Anido told Healio.com/OSN in company correspondence. “Finally, the study confirms that Rhopressa works equally well in patients whether they have high or low baseline pressures. We are very excited about this additional evidence of its broad utility.”
Conjunctival hyperemia was the most common adverse event, observed in 23.6% of patients in the 0.01% arm, 37% in the 0.02% arm, 56.9% in the 0.04% arm and 1.8% in the placebo arm.
Aerie will meet with Japan’s Pharmaceutical and Medical Devices Agency to discuss a phase 3 program in Japan. – by Rebecca L. Forand