Aerie Pharmaceuticals announced the commencement of patient dosing in Mercury 3, the company’s European phase 3 clinical trial of Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a novel once-daily eye drop that has demonstrated in US clinical trials its ability to lower IOP in patients with open-angle glaucoma or ocular hypertension. Roclatan is a fixed dose combination of Aerie product candidate Rhopressa (netarsudil ophthalmic solution) 0.02% and latanoprost, the most widely prescribed PGA (prostaglandin analogue).
Mercury 3 has been designed to facilitate regulatory approval and commercialization in Europe and is not necessary for approval in the United States. As background, Aerie has completed all phase 3 registration trial activity necessary for a Roclatan new drug application (NDA) filing with the FDA, which is expected to be submitted in the first half of 2018.
The company estimates a total enrollment of approximately 500 patients in Mercury 3, a two-arm, 6-month safety trial that also provides a 90-day interim efficacy readout comparing once-daily Roclatan for non-inferiority to Ganfort, a widely prescribed fixed dose combination IOP-lowering therapy marketed in Europe, but not in the United States. Each comparator arm will be dosed once daily in the evening. Patients will be evaluated with maximum baseline IOPs ranging from above 20 to below 36 mmHg (millimeters of mercury). The trial will be conducted primarily in the United Kingdom, France, Germany, Italy, Spain, and Belgium.
“This is the beginning of a new chapter for Aerie as we start our first phase 3 clinical trial in Europe. We are pleased to have commenced Mercury 3 on schedule, and we currently expect to read out topline 90-day efficacy data for the trial by early 2019. As we continue to expand our global reach we also look forward to commencing our Rhopressa clinical program designed to address the Japanese market, scheduled to begin later in 2017,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.