In the phase 3 Rocket 4 trial, Rhopressa at 6 months showed consistent safety data with previous phase 3 clinical trials of Rhopressa and remained within the non-inferiority range compared with timolol, according to Aerie Pharmaceuticals.
The trial included 708 patients with open-angle glaucoma or ocular hypertension across 52 sites in the U.S., randomized 1:1 to receive either once-daily Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals) or twice-daily timolol for 6 months, Vicente Anido Jr., PhD, chairman and CEO of Aerie, said during a conference call about the study results.
Ocular and systemic safety of the patients was evaluated during the 6-month treatment period, he said.
The 90-day primary efficacy endpoint results were previously reported.
The most common adverse event was conjunctival hyperemia. About 48% of patients developed the adverse event through 6 months, but only 10% of patients had hyperemia on each study visit day from week 2 to month 6, and only 4% of patients discontinued Rhopressa due to hyperemia, Anido said.
Furthermore, Anido noted that since achieving the primary study endpoint of non-inferiority to timolol at 3 months, Rhopressa remained within the non-inferiority range at months 4, 5 and 6.
“Rhopressa demonstrated consistent levels of IOP lowering across all baseline IOPs in the trial and consistent IOP lowering through the 6 months we measured,” Anido said in the call.
The 6-month safety data from the Rocket 4 trial are intended to be used for regulatory filing for European approval, which is expected to take place in the second half of 2018.