Glaucoma drug meets primary endpoint

Rhopressa showed non-inferiority to timolol in glaucoma patients with a baseline IOP below 25 mm Hg, reports Aerie Pharmaceuticals.

In April, the drug failed to meet a primary endpoint of non-inferiority to timolol in patients with a baseline IOP below 27 mm Hg. But 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.

In this second study, Rocket 2, the endpoint range of 20 mm Hg to 27 mm Hg was a secondary endpoint. However, Rhopressa did not show non-inferiority to timolol for the secondary endpoint.

The Rocket 2 trial included 756 glaucoma patients randomized 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.

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.

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.