Aerie Pharmaceuticals has started dosing patients in a Phase II clinical trial being conducted to evaluate netarsudil ophthalmic solution (Rhopressa).
Rhopressa eye drops are being developed to target the eye’s trabecular meshwork of primary fluid drain and the diseased tissue that causes elevated intraocular pressure (IOP) in cases of glaucoma.
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Being conducted in the US, the Phase II trial will enrol 60 Japanese and Japanese-American subjects as a precursor for future Phase III trials being planned to be performed in Japan.
The trial aims to establish non-inferiority in the ocular hypotensive activity of once-daily 0.02% and 0.04% dose concentrations of netarsudil solution compared to placebo over a period of 28 days.
Additionally, the ocular and systemic safety of the solution during the treatment period will be compared to that of the placebo.
The baseline IOP ranges in the trial include greater than or equal to 15mmHg to less than 35 millimetres of mercury (mmHg) for open-angle glaucoma patients, and higher than 22mmHg to lower than 35mmHg for subjects with ocular hypertension.
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By GlobalDataAerie Pharmaceuticals chairman and CEO Vicente Anido said: “Studies in Japan have shown that Japanese glaucoma patients experience IOPs that are generally lower than those experienced in the US and Europe, hence the IOP ranges in this study start at 15mmHg.
“The Japanese glaucoma market is one of the largest in the world at approximately $1bn annually, and we believe there continues to be substantial unmet need in this market.”
The Phase II trial is being performed in accordance with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) requirements and is expected to support the potential regulatory submission for netarsudil ophthalmic solution in the country.
