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October 13, 2021

Aerie reports positive Phase III data for netarsudil ophthalmic solution 

Conjunctival hyperemia was the most common treatment-emergent adverse event reported in the trial.

Aerie Pharmaceuticals has reported positive data from the Phase III clinical trial in Japan assessing netarsudil ophthalmic solution 0.02% to treat open-angle glaucoma and elevated intraocular pressure (IOP).

According to the findings, a once-daily dose of netarsudil 0.02% was demonstrated to be superior to a twice-daily dose of ripasudil 0.4% in reducing IOP at week four, meeting the primary goal of the trial.

Netarsudil 0.02% and ripasudil 0.4% are inhibitors of Rho kinase (ROCK).

They can potentially treat open-angle glaucoma and elevated IOP by boosting aqueous humour outflow through the trabecular outflow pathway.

This drainage pathway is responsible for preserving normal IOP in the eye.

The randomised, parallel-group, multicentre Phase III trial analysed the ocular hypotensive efficacy and safety of netarsudil 0.02% versus ripasudil 0.4% for a four-week duration in subjects with open-angle glaucoma or ocular hypertension.

It enrolled a total of 245 patients, who received either netarsudil 0.02% or ripasudil 0.4%.

The primary efficacy endpoint of mean diurnal IOP was statistically significantly lower in the netarsudil 0.02% arm versus the ripasudil 0.4% arm at week four.

The treatments were also demonstrated to be safe and well-tolerated in the trial.

Conjunctival hyperemia was the most common treatment-emergent adverse event, with most of the ocular adverse events reported to be mild in nature.

Aerie Pharmaceuticals interim executive chairman Benjamin McGraw said: “We are pleased to have successfully completed our first Phase III 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.

“The IOP-lowering with netarsudil was consistent with that seen in the previous Phase II study conducted in Japan as well as in our ROCKET and MERCURY studies conducted in the US for Rhopressa and Rocklatan, respectively.”

Last month, Aerie announced positive top-line data from the Phase IIb COMET-1 trial of the AR-15512 ophthalmic solution for the treatment of dry eye disease.

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