September 24, 2020
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Roclanda displays non-inferiority in phase 3b trial

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Interim results from a phase 3b clinical trial in Europe showed Roclanda was non-inferior to Ganfort, according to a press release.

The Mercury 3 trial compared IOP reduction in patients with open-angle glaucoma or ocular hypertension. The randomized, masked study included about 430 patients who received study medication once daily each evening.

The 90-day topline data showed that Roclanda (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution, Aerie Pharmaceuticals), marketed as Rocklatan in the United States, met the overall study objective by demonstrating non-inferiority to Ganfort (bimatoprost/timolol, Allergan) across nine time points over 90 days.

Roclanda showed consistent IOP reduction of about 37% throughout the day, which was consistent with data for Ganfort, according to the release.

“We believe these interim topline results point to consistent pricing levels for the two comparators in the trial. While we expect to receive approval for Roclanda by early next year, we will wait for further clarity on U.S. pricing ramifications before determining the nature and timing of launch plans in Europe,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release.

IOP reductions in Mercury 3 exceeded reductions from Mercury 1 and 2, and the trial also displayed a lower incidence of ocular adverse events.

Aerie expects 6-month topline results to be available in early 2021.