Aerie Pharmaceuticals Announces Successful Interim 90-Day Topline Data From Its Six-Month Mercury 3 Clinical Trial in Europe
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today announced successful interim 90-day topline data from its six-month Phase 3b clinical trial in Europe known as Mercury 3, comparing Roclanda to Ganfort.
Roclanda is marketed in the United States as Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. Ganfort is approved for use in Europe but is not approved for use in the United States.
Mercury 3 was designed as a non-inferiority trial to compare intraocular pressure (IOP) reduction in patients with open-angle glaucoma or ocular hypertension.
Interim 90-Day Topline Highlights:
- Roclanda met the overall trial objective by demonstrating non-inferiority to Ganfort across nine of nine timepoints over 90 days.
- Roclanda demonstrated consistent IOP reduction throughout the day of approximately 9.5 millimeters of mercury (mmHg) for an average reduction from baseline IOPs of approximately 37 percent.
- The IOP reductions observed in Mercury 3 exceeded those from both Mercury 1 and Mercury 2.
- The IOP reduction results for Roclanda were highly consistent with those of Ganfort.
- Incidence of ocular adverse events for Roclanda were lower than observed in Mercury 1 and Mercury 2.
- Six-month topline results are expected by early 2021.
“We are pleased to have another set of clinical trial data that yet again reinforces the excellent efficacy profile of Rocklatan. As background, Mercury 3 is not necessary for regulatory approval in Europe but rather is intended to elucidate its pricing and commercialization prospects in that region,” said Vicente Anido Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “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.”
About the Mercury 3 Clinical Trial and Comparators
Mercury 3 was designed as a non-inferiority trial to compare intraocular pressure (IOP) reduction in patients with open angle glaucoma or ocular hypertension. Approximately 430 subjects satisfying inclusion criteria were randomized to one of two arms and received masked study medication once-daily in the evening.