Rhopressa meets primary endpoint in Rocket 2 trial

Rhopressa showed non-inferiority to timolol in glaucoma patients with baseline IOP below 25 mm Hg in a phase 3 clinical trial, Aerie Pharmaceuticals announced.

Vicente Anido Jr., PhD, CEO of Aerie, reviewed results of the Rocket 2 trial during a company-sponsored conference call.

“This is obviously a really great day for our company. We’ve been on quite a roller coaster ride since April 23, when we released results of Rocket 1. We’re very happy with the successful result of Rocket 2. I think the results pretty much speak for themselves,” Anido said. “We did achieve our primary endpoint, which is baseline below 25 mm Hg and above 20 mm Hg for both Rhopressa once a day and twice a day. They were both non-inferior to timolol across the nine time points that we measured.”

Results of the Rocket 1 trial, reported in April, showed that Rhopressa did not meet its primary endpoint of non-inferiority to timolol in patients with a baseline IOP below 27 mm Hg. In June, the FDA allowed Aerie to change the primary endpoint range to include patients with a baseline IOP ranging from above 20 mm Hg to under 25 mm Hg.

The endpoint range of 20 mm Hg to 27 mm Hg was a secondary endpoint in Rocket 2.

The Rocket 2 trial included 756 glaucoma patients randomized 1:1:1 to receive Rhopressa 0.02% once daily, Rhopressa 0.02% twice daily or timolol 0.5% twice daily. A total of 403 patients participated under the revised protocol of baseline IOP ranging from 20 mm Hg to 25 mm Hg.

IOP reduction was consistent in comparison to timolol, Anido said.

“We were able to show non-inferiority to timolol BID on both the Rhopressa QD as well as the BID arm, based on primary analysis for patients below 25 mm Hg,” he said.

However, Rhopressa did not show non-inferiority to timolol for the secondary endpoint, baseline IOP of 20 mm Hg to 27 mm Hg, Anido said.

“We only missed non-inferiority at two out of the nine time points, and in both of those we missed by roughly 0.3 of a point. So, it was barely a miss,” he said.

Rhopressa showed a similar adverse event profile in Rocket 2 compared with Rocket 1.

The most common adverse event was conjunctival hyperemia, with a 35% incidence in the once-daily arm and a 50% incidence in the twice-daily arm.

“Now that we have two phase 3 trials on Rhopressa, we do think we have a proven once-daily intraocular pressure-lowering agent. The triple mechanism action does seem to be playing out, and it will be the first drug that specifically targets the trabecular meshwork, which, as you know, is damaged tissue that leads to glaucoma,” Anido said.

Aerie expects to file a new drug application with the FDA in mid-2016. Rocket 4, a fourth phase 3 clinical trial, is expected to begin by the end of September. – by Matt Hasson