Aerie Pharma reports positive results from Rocket 4 Phase III trial of Rhopressa (netarsudil ophthalmic solution) for glaucoma and ocular hypertension.

Aerie Pharmaceuticals, Inc. reported the successful 90-day topline efficacy results of its Rocket 4 Phase III clinical trial of product candidate Rhopressa, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The Rocket 4 trial is designed to provide adequate six-month safety data for European regulatory filing purposes. Rocket 4 is not necessary for NDA filing purposes.

Rocket 4 enrolled a total of approximately 700 patients and is a two-arm six-month trial, which includes a 90-day efficacy readout evaluating once-daily Rhopressa for non-inferiority to twice-daily timolol. The range for the primary endpoint includes patients with baseline IOPs from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The study achieved its primary efficacy endpoint demonstrating non-inferiority of once-daily Rhopressa compared to twice-daily timolol. Separately, Aerie announced that it has withdrawn the Rhopressa NDA (new drug application) that was submitted to the FDA in the third quarter of 2016. The filing was withdrawn as the result of a third party manufacturing facility in Tampa, Florida not being ready for pre-approval inspection by the FDA. The drug product contract manufacturer has advised Aerie and the FDA that it expects to be prepared for FDA inspection in January 2017, and Aerie expects to resubmit the Rhopressa NDA filing at that time.