Aerie Completes Enrollment Of Rocket 4 Final Stage Clinical Study Of RhopressaTM 0.02%

Aerie Pharmaceuticals, Inc. AERI disclosed the completion of patient enrollment in Rocket 4, its final stage clinical study for RhopressaTM (netarsudil ophthalmic solution) 0.02% intended to satisfy filing requirements in Europe. According to the company, RhopressaTM is a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Aerie said Rocket 4 achieved total enrollment of approximately 700 patients and is a two-arm 90-day efficacy study, comparing once-daily RhopressaTM for non-inferiority to twice-daily timolol. The company added that the range for the primary endpoint mirrors its successful Rocket 2 study, including patients with baseline IOPs ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The company indicated that its Rocket 4 included a secondary endpoint range of baseline IOPs from above 20 mmHg to below 27 mmHg, and additionally a secondary endpoint timeframe of six months.

The company's Chairman and CEO, Vicente Anido, said, "Rocket 4, while not needed for our RhopressaTM NDA filing expected to be submitted next quarter, is designed to provide adequate RhopressaTMsafety data for our future expected filings with the European regulatory authorities. Europe represents a very large glaucoma market, and we expect to file for European approval of RhopressaTM in the second half of 2017."