Aerie Pharmaceuticals (NSDQ:AERI) said today that it completed enrollment for its 2nd phase III registration trial, Mercury 2, evaluating its Roclatan once-daily eye drops for intraocular pressure resulting from glaucoma or ocular hypertension.
The company’s Roclatan solution is a fixed dose combination of its drug Rhopressa (netarsudil ophthalmic solution) and latanoprost, a widely prescribed prostaglandin analogue. More than 690 patients are enrolled in the 3-arm study, comparing the Roclatan solution to each of its individual components.
“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,” chairman & CEO Vicente Anido, Jr., said in prepared remarks.
In September, the company touted successful topline efficacy results from its 1st phase III registration trial, Mercury 1, for Roclatan. The trial achieved its primary efficacy endpoint, demonstrating superiority over its components. Aerie said it will launch a 3rd phase III registration for Roclatan in the 1st half of 2017, which will be designed to support regulatory approval and commercialization efforts in Europe.