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Rhopressa shows positive topline efficacy results in Rocket 4 phase 3 trial

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The Rocket 4 phase 3 trial of the once-daily eye drop Rhopressa has shown positive topline 90-day efficacy results in lowering IOP in patients with glaucoma or ocular hypertension, Aerie announced in a press release.

In the Rocket 4 study, which included approximately 700 patients, Rhopressa (netarsudil ophthalmic solution 0.02%) demonstrated non-inferiority compared to twice-daily timolol in patients with baselines above 20 mmHg to below 25 mmHg, according to the release.

“Rocket 4 is designed to provide adequate 6-month Rhopressa safety data for our filing with the European regulatory authorities,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said.

The trial is expected to be completed by early 2017.

In addition, Aerie announced it has withdrawn the new drug application for Rhopressa that was filed recently with the FDA due to a third-party manufacturing facility’s lack of preparedness for FDA pre-approval inspection.

“We plan on refiling the NDA in January 2017, which is when we and the FDA have been advised by our contract manufacturer that they expect to be prepared for FDA inspection,” Anido said.