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Aerie intends to initiate more trials and file NDA in 2016
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Having initiated its fourth phase 3 trial for Rhopressa and its first phase 3 registration trial for Roclatan, Aerie pharmaceuticals is heading into 2016 with the intention of filing a new drug application for Rhopressa and beginning two more phase 3 trials for Roclatan, according to company press releases.
Rhopressa is a triple-action IOP-lowering eye drop, and Roclatan is a fixed-dose combination of Rhopressa and latanoprost.
In the Rocket 1 trial, reported in April, Rhopressa did not meet its primary endpoint of non-inferiority to timolol in patients with a baseline IOP less than 27 mm Hg. In June, the FDA allowed Aerie to change the primary endpoint range to include patients with a baseline IOP of more than 20 mm Hg to less than 25 mm Hg. This primary endpoint was met in Rocket 2.
“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,” Vicente Anido Jr., PhD, CEO of Aerie, said during a company-sponsored conference call.
The endpoint range of 20 mm Hg to 27 mm Hg was a secondary endpoint in Rocket 2. IOP reduction was consistent in comparison to timolol, but Rhopressa did not show non-inferiority to timolol for the secondary endpoint, Anido said.
Rocket 3 is a 12-month safety-only study underway in Canada, and the first patient has been dosed in Rocket 4, the fourth phase 3 clinical trial of Rhopressa.
Efficacy results of Mercury 1, a superiority trial of Roclatan compared with its two components, and initiation of two more phase 3 trials are expected in 2016, according to a company release. – by Matt Hasson and Kate Sherrer