Aerie Pharmaceuticals a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, has announced that dosing commenced on the first patients enrolled in Rocket 4, the company’s fourth Phase 3 clinical trial of RhopressaTM, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Aerie anticipates total enrollment of approximately 700 patients in this two-arm 90-day efficacy study, comparing once-daily RhopressaTM for non-inferiority to twice daily timolol. The range for the primary endpoint mirrors Aerie’s successful Rocket 2 trial, and includes patients with baseline IOPs ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The 90-day efficacy results of this study are expected to be reported in approximately one year. Rocket 4 also includes a secondary endpoint range of baseline IOPs from above 20 mmHg to below 27 mmHg, and also a secondary endpoint timeframe of six months. Rocket 4 is designed to provide six-month safety data for a minimum of 300 patients to support expected future filings for regulatory approval in Europe. To ensure a proper cohort of patients in the study for primary and secondary endpoint purposes, Rocket 4 includes enrollment of patients with baseline IOPs up to 30 mmHg.
“Based on our prior discussions with the FDA, and the successful Rocket 2 results we announced last week, we remain on track to file our RhopressaTM NDA in mid-2016. The Rocket 4 clinical trial design includes the same clinical endpoint ranges used for our successful Rocket 2 clinical trial, from above 20 mmHg to below 25 mmHg, and is designed to provide additional clinical data for RhopressaTM and adequate six-month safety data to prepare us for our future expected European regulatory filings,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “In addition to looking forward to the results of Rocket 4 in about a year, we continue to learn more about this drug as we further analyze the successful Rocket 2 clinical trial results in addition to new preclinical research findings, the results of which we expect to share on November 13, 2015, at our event at the AAO (American Academy of Ophthalmology) meeting in Las Vegas, Nevada.”