The eye drug is a fixed dose combination of Aerie’s Rhopressa netarsudil ophthalmic solution and a widely-used prostaglandin analogue, latanoprost. The company’s Phase III trial was designed to support regulatory approval and commercialization in Europe, Aerie said.
The 500-patient, six-month safety trial also includes a 90-day interim efficacy readout, the company reported, comparing once-daily Roclatan for non-inferiority to Ganfort – a fixed dose therapy sold in Europe designed to lower intraocular pressure.
Aerie said it has finished all Phase III registration study activity required for a new drug application for Roclatan in the U.S. and that it plans to submit the NDA in the first half of next year.
“This is the beginning of a new chapter for Aerie as we start our first Phase III 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,” chairman & CEO Vicente Anido, Jr., said in prepared remarks.
In July, Aerie touted 12-month safety data from the U.S.-based Phase III registration trial of its Roclatan eye drops.
Safety data for the 12-month study period were consistent with results observed during the 90-day efficacy period in the Mercury 1 trial. Aerie reported that there were no new adverse events that developed following the initial 90-day period.
The most common adverse event was eye redness, which was reported in 60% of patients.
Intraocular pressure was also measured throughout the 12-month study period, Aerie said, and Roclatan lowered IOP better than latanoprost and Aerie’s Rhopressa – consistent with results observed in the initial 90-day study period.