Aerie Pharmaceuticals announced that it resubmitted its new drug application (NDA) for Rhopressa to the FDA after notification by its contract drug product manufacturer that the vendor’s Tampa, Florida facility is now ready for preapproval inspection by the FDA. The Rhopressa NDA was withdrawn in October 2016 due to the contract manufacturer not yet being prepared for preapproval inspection by the FDA at that time.
“We are delighted to have our Rhopressa NDA filing back on track, and we expect a standard 12-month FDA review process from the date of resubmission. Pending approval, we anticipate product launch in the second quarter of 2018,” Vicente Anido, Jr., PhD, Chief Executive Officer and Chairman at Aerie, said in a company news release.
“Looking forward to additional upcoming milestones, we continue to expect in the second quarter of 2017, the readout of the 6-month safety and efficacy data for the Rhopressa phase 3 registration trial, known as Rocket 4," Dr. Anido said. "We also anticipate in the second quarter of 2017, the readout of the 90-day efficacy data from Mercury 2, our second phase 3 registration trial for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%."