Netarsudil meets IOP-lowering endpoint in phase 3 trial in Japan
Netarsudil 0.02% appears to be more effective at lowering IOP in patients with open-angle glaucoma or ocular hypertension than ripasudil 0.4% in a phase 3 clinical trial, according to a press release from Aerie Pharmaceuticals.
“We are pleased to have successfully completed our first phase 3 clinical trial in Japan which further confirmed that netarsudil ophthalmic solution 0.02% achieves impressive IOP-lowering efficacy in a patient population with lower baseline pressures,” Benjamin F. McGraw III, PharmD, interim executive chairman at Aerie, said in the release.
The randomized, multicenter, parallel-group trial investigated efficacy and safety of netarsudil 0.02% administered once daily in 122 subjects compared with ripasudil 0.4% administered twice daily in 123 subjects over a 4-week period.
At week 4, the primary endpoint of the study, the mean diurnal IOP was statistically significantly lower in the netarsudil group (16 mm Hg) than the ripasudil group (17.7 mm Hg) (P < .0001). The change was 4.7 mm Hg from baseline in the netarsudil group compared with 3 mm Hg from baseline in the ripasudil group (P < .0001).
Both medications were well tolerated. The most common treatment-emergent adverse event was conjunctival hyperemia, experienced by 54.9% of netarsudil subjects and 62.6% of ripasudil subjects.
Aerie and Santen hold a collaboration and license agreement for Rhopressa (netarsudil ophthalmic solution 0.02%) and Rocklatan (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution) in Japan and other Asian countries, with the companies collaborating on this trial and Santen being responsible for all regulatory processes and commercialization.