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Rocket 4 efficacy trial for Rhopressa underway

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Aerie Pharmaceuticals announced the first patient was dosed in a fourth phase 3 clinical trial of Rhopressa, according to a press release.

Rhopressa is a triple-action eye drop undergoing testing for its ability to lower IOP in patients with glaucoma or ocular hypertension.

Aerie expects to enroll around 700 patients in the 90-day efficacy study to compare once-daily Rhopressa for non-inferiority with twice-daily timolol, according to the release. The primary endpoint is similar to the Rocket 2 trial and includes patients with baseline IOP from more than 20 mm Hg to less than 25 mm Hg. The secondary endpoint range includes patients with baseline IOP from more than 20 mm Hg to less than 27 mm Hg. Ninety-day efficacy results are expected to be released in 1 year.

The trial has a secondary endpoint time of 6 months to provide 6-month safety data for at least 300 patients. This would support regulatory approval filings in Europe.

Aerie remains on track to file a new drug application for Rhopressa in mid-2016, Vicente Anido Jr., PhD, Aerie chairman and CEO, said in the release.