Aerie Pharmaceuticals announced the completion of patient enrollment in the company’s second phase 3 registration trial (Mercury 2) of Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a once-daily eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension.
Roclatan is a fixed dose combination of Aerie’s drug Rhopressa (netarsudil ophthalmic solution) 0.02% and latanoprost, the most widely prescribed PGA (prostaglandin analogue). Total patient enrollment has exceeded the 690 patients needed for this three-arm study, designed to demonstrate superiority of Roclatan solution to each of its two components, all dosed once-daily in the evening. Enrolled patients had maximum baseline IOPs ranging from above 20 to below 36 mmHg. Mercury 2, which commenced in March 2016, is a 90-day registration trial with a topline efficacy readout that is expected in the second quarter of 2017.
In September 2016, the company reported the successful topline efficacy results from the first phase 3 registration trial for Roclatan ophthalmic solution, Mercury 1, which achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components at all measured time points. Mercury 1 and Mercury 2 have the same comparators and primary efficacy endpoints, and also include the same baseline IOP entry criteria. Mercury 1 is an ongoing 12-month safety trial, whereas Mercury 2 is a 90-day trial. Aerie also plans to commence in the first half of 2017 a third phase 3 registration trial for Roclatan, named Mercury 3, which will be designed to facilitate regulatory approval and commercialization in Europe.
“With the completion of Mercury 2 enrollment, we remain well-positioned for the topline 90-day efficacy readout from this second Roclatan registration trial in the second quarter of 2017. Should Mercury 2 be successful, we continue to expect to file an NDA for Roclatan ophthalmic solution near year-end 2017. We continue to experience very high levels of interest in Roclatan from the ophthalmology community, and we look forward to the continued successful progress of our registration program,” Vicente Anido, Jr., PhD, Chief Executive Officer and Chairman at Aerie, said in a company news release.