Rocklatan achieves non-inferiority to Ganfort and outperforms prior Phase 3 trials
Aerie Pharmaceutical’s novel, once-daily, eye drop Rocklatan, which demonstrated an ability to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, announced successful interim 90-day topline data from its 6-month Phase 3b clinical trial in Europe. Rocklatan achieved non-inferiority to Ganfort (bimatoprost and timolol) for IOP reduction and its Mercury 3 performance exceeded prior Phase 3 trials.
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Rocklatan, marketed as Roclanda in Europe, (netarsudil/latanoprost ophthalmic solution) is a fixed-dose combination of Rhopressa (netarsudil ophthalmic solution) 0.02% and prostaglandin analog latanoprost. Ganfort is approved for use in Europe but not in the U.S.
Rocklatan met the overall trial objective by demonstrating non-inferiority to Ganfort across 9 of 9 timepoints within 90 days. Rocklatan also demonstrated consistent IOP reduction throughout the day of approximately 9.5 millimeters of mercury (mm Hg) for an average reduction from baseline IOPs of approximately 37 percent, according to the company.
The IOP reduction results for Rocklatan were highly consistent with those of Ganfort and exceeded those from both Mercury 1 and Mercury 2. Additionally, incidence of ocular adverse events for Rocklatan were lower than observed in Mercury 1 and Mercury 2.
The company’s European Phase 3 clinical trial, Mercury 3, is not necessary for regulatory approval in Europe but rather is intended to elucidate its pricing and commercialization prospects in that region, says Vicente Anido Jr., PhD, chairman and chief executive officer at Aerie.
“We believe these interim topline results point to consistent pricing levels for the 2 comparators in the trial,” he says. “While we expect to receive approval for Roclanda(Rocklatan) 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.”