Aerie Pharmaceuticals announced successful interim 90-day topline data from its 6-month phase 3b clinical trial in Europe known as Mercury 3, comparing Roclanda to Ganfort, according to a company news release.
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 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,” Vicente Anido Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.
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.”
Rocklatan is the only fixed-dose combination product commercially available in the United States that includes a prostaglandin analog. The Ganfort fixed-dose combination includes a prostaglandin analog and a beta blocker, and while it is approved for use in Europe, it is not approved for use in the United States.