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Aerie Announces Positive Phase 3 Results For Netarsudil Ophthalmic Solution 0.02% Trial In Japan

Aerie Pharmaceuticals Inc. (AERI) said it has successfully completed its first phase 3 clinical trial in Japan which further confirmed that netarsudil ophthalmic solution 0.02% achieves impressive intraocular pressure or IOP-lowering efficacy in a patient population with lower baseline pressures.

In Tuesday pre-market trade, AERI was trading at $14.29 up $1.24 or 9.50%.

The IOP-lowering with netarsudil was consistent with that seen in the previous Phase 2 study conducted in Japan as well as in ROCKET and MERCURY studies conducted in the United States for Rhopressa and Rocklatan, respectively.

Phase 3 clinical trial in Japan evaluated netarsudil ophthalmic solution 0.02% versus ripasudil hydrochloride hydrate ophthalmic solution 0.4% or "ripasudil 0.4%". The results showed that netarsudil 0.02% once daily was superior to ripasudil 0.4% twice daily in lowering intraocular pressure at week four, the primary endpoint for the study.

Both netarsudil 0.02% and ripasudil 0.4% are Rho kinase (ROCK) inhibitors. They are designed to treat open-angle glaucoma and elevated IOP by increasing outflow of aqueous humor through the trabecular outflow pathway, the drainage pathway responsible for maintaining normal IOP in the eye.

The company noted that the findings also suggest that the IOP reduction may predict strong efficacy in normal or low-tension glaucoma patients.These patients suffer damage to the optic nerve in spite of having IOPs in the normal range. Historically it has been challenging to achieve the IOP reductions needed to prevent vision loss in this patient population.

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