Aerie pharmaceuticals, inc. reports positive topline results for the phase 2 clinical trial evaluating netarsudil ophthalmic solution in japanese patients

Aerie pharmaceuticals, inc. reported positive topline results for the company's phase 2 clinical trial evaluating netarsudil ophthalmic solution in japanese patients. netarsudil is a rho kinase (rock) inhibitor specifically designed to increase outflow of aqueous humor through the trabecular meshwork, the eye's primary drainage pathway. netarsudil ophthalmic solution 0.02% is known by the name rhopressa in the united states and is approved for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. it is also under regulatory review in the european union, where it is called rhokiinsa . the netarsudil ophthalmic solution 0.01% concentration reduced mean diurnal iop by a range of 4.1 to 4.6 mmhg, the 0.02% concentration reduced mean diurnal iop by a range of 4.4 to 4.8 mmhg, and the 0.04% concentration reduced mean diurnal iop by a range of 4.8 to 5.1 mmhg. the placebo arm reduced mean diurnal iop by a range of 1.4 to 1.7 mmhg. the ranges reflect iop measurements taken at week 1, week 2 and week 4. iop lowering was consistent across the measurement period. the most common adverse event was conjunctival hyperemia, which when measured by biomicroscopy, was observed in 23.6% of subjects in the netarsudil 0.01% arm, 37.0% of subjects in the netarsudil 0.02% arm, 56.9% of subjects in the netarsudil 0.04% arm, and 1.8% in the placebo arm. the level of conjunctival hyperemia observed in the netarsudil 0.02% arm was notably less than levels observed in the clinical trials for rhopressa previously conducted in the united states. the large majority of the conjunctival hyperemia was considered mild. there were no serious adverse events. the topline results of this large phase 2 study confirm that netarsudil ophthalmic solution maintains strong iop-lowering efficacy in a patient population with lower baseline pressures, a clinical need that remains unmet by currently available glaucoma therapeutics in japan, the united states and in europe said vicente anido, jr., ph.d., chairman and chief executive officer at aerie. these findings, which will be presented in full at an upcoming ophthalmic congress, also suggest that the concentration of netarsudil that provides the best balance of efficacy and tolerability in this population is 0.02%, which is the concentration for rhopressa currently marketed in the united states. the company will now look to meet with japan's pharmaceutical and medical devices agency to discuss these results and identify next steps for a phase 3 program in japan. with this data in hand is advancing a number of different activities, including potential partnering discussions, to gain approval and ultimately commercialize the company's products in japan.
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