Aerie Pharma reports Phase III results of Rhopressa for glaucoma and ocular hypertension

Aerie Pharmaceuticals, Inc. reported the successful results of its second Phase III trial for Rhopressa, 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. The trial achieved its primary efficacy endpoint demonstrating non-inferiority of Rhopressa compared to timolol, the most widely used comparator. Rhopressa, dosed both once-daily and twice-daily, achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg (millimeters of mercury). The Rocket 2 efficacy results for Rhopressa demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period. The most common Rhopressa adverse event was hyperemia, or eye redness, which was reported as increased in 35 percent of patients and was scored as mild for 83 percent of patients in the Rhopressa once-daily arm of the trial. The adverse event profile for the Rhopressa once-daily arm was consistent with the results of Rocket 1. As expected, Rhopressa dosed twice-daily generated a higher incidence of adverse events and was slightly more efficacious than Rhopressa dosed once-daily.

Comment: With these successful Rocket 2 results, and the performance of Rhopressa in Rocket 1 study at baseline IOPs below 25 mmHg, Aerie expects to file its NDA for Rhopressa in mid-2016.

Comment; In Rocket 1 study, the results of which were initially reported in April 2015, was a 90-day efficacy trial that did not achieve its primary endpoint, but did achieve its pre-specified secondary endpoint.

Comment; The drug had failed to meet non-inferiority criteria in ROCKET 1 in those with IOP below 27 mm Hg (the primary endpoint of that study), but did so in those with lower baseline IOPs (below 26 mm Hg and lower), even performing numerically better than timolol in that study. In the current study, Rhopressa also failed to meet non-inferiority in those with IOP below 27 mmHg.