Aerie Pharmaceuticals has reported positive top-line results from the Phase II clinical trial of netarsudil ophthalmic solution conducted in open-angle glaucoma or ocular hypertension patients in Japan.
Netarsudil is a Rho-kinase (ROCK) inhibitor that boosts outflow of aqueous humour through the eye’s trabecular meshwork.
The drug is approved in the US under the name Rhopressa and aims to decrease elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The Japanese Phase II study assessed 0.01%, 0.02% and 0.04% of netarsudil ophthalmic for 28 days and tested its safety and ability to reduce IOP compared to placebo.
Of the total 215 patients enrolled, 207 completed the trial. The primary endpoint was mean diurnal IOP on day 29.
Data showed that mean diurnal IOP at day 29 was statistically significantly lesser in participants who received netarsudil treatment versus patients in the placebo arm.
Mean diurnal IOP was 4.1 to 4.6mmHg, 4.4 to 4.8mmHg, and 4.8 to 5.1mmHg for the 0.01%, 0.02% and 0.04% concentrations, respectively. However, the placebo group had a range of 1.4 to 1.7mmHg.
The most common adverse event during the trial was conjunctival hyperemia.
Results from the Phase II trial are expected to support Phase III trials for the regulatory submission of netarsudil ophthalmic solution in Japan
Aerie Pharmaceuticals chairman and CEO Vicente Anido said: “We will now look to meet with Japan’s Pharmaceutical and Medical Devices Agency to discuss these results and identify next steps for a Phase III programme in Japan.
“With this data in-hand, we are advancing a number of different activities, including potential partnering discussions, to gain approval and ultimately commercialise our products in Japan.”
The drug is also being reviewed by the European regulatory authority under the name Rhokiinsa.