22 March 2019 - - US-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) has started patient dosing in its Phase 2 clinical trial designed in accordance with the requirements of Japan's PMDA (Pharmaceuticals and Medical Devices Agency) to support potential regulatory submission of netarsudil ophthalmic solution in Japan, the company said.

Netarsudil ophthalmic solution 0.02% is known by the name Rhopressain the United States and is approved for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

This Phase 2 trial is being conducted in Japan as a precursor to Phase 3 registration trials in that country.

The prospective, double-masked, multi-center, placebo-controlled, parallel group study is designed to evaluate the IOP-reducing effect and safety of three concentrations of netarsudil ophthalmic solution over a 28-day period.

Entry criteria include unmedicated baseline IOP ranges at 9:00 AM of 15 mmHg (millimeters of mercury) to less than 35 mmHg for patients with open-angle glaucoma, and 22 mmHg to less than 35 mmHg for patients with ocular hypertension.

A total of approximately 208 patients will be randomized equally across four treatment arms: netarsudil ophthalmic solution 0.01%, netarsudil ophthalmic solution 0.02%, netarsudil ophthalmic solution 0.04%, and placebo, all administered once daily in the evening.

As agreed with the PMDA, the design of this trial is consistent with that of a recent Phase 2 pilot study conducted in a Japanese-American population in the United States, with the addition of the netarsudil ophthalmic solution 0.01% treatment arm to confirm the concentration of netarsudil most suitable for this population.

Studies of glaucoma in Japan suggest that patients have baseline IOP that is generally lower than those experienced by patients in the United States and Europe, hence the IOP range in the netarsudil Japanese Phase 2 trials begins lower, at 15 mmHg.

Topline results of the Phase 2 pilot study in Japanese Americans were announced in January 2019.

In that study, netarsudil ophthalmic solution 0.02% reduced mean diurnal IOP by a range of 5.0 to 5.3 mmHg in patients with an average baseline IOP of 18.3 mmHg.

Netarsudil ophthalmic solution 0.04% reduced mean diurnal IOP by a range of 5.2 to 6.6 mmHg in patients with average baseline IOP of 20.2 mmHg.

Both netarsudil arms produced significantly greater IOP reduction than placebo at Day 28. The safety findings were consistent with previous netarsudil trials.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye.

Aerie's first product, Rhopressa (netarsudil ophthalmic solution) 0.02%, a once-daily eyedrop approved by the US Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018.

In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.

Aerie's second product for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost, has been approved by the FDA and is expected to be launched in the United States in 2Q19.

In clinical trials of Rocklatan, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage.

Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema.