Aerie Pharmaceuticals announced that its sterile fill production facility in Athlone, Ireland has received approval from the FDA for production of Rhopressa (netarsudil ophthalmic solution) 0.02% for commercial distribution in the United States. This approval comes following the FDA review of the New Drug Application Prior Approval Supplement (PAS), which added the Athlone production facility as a drug product manufacturer for Rhopressa.
“The PAS approval for Rhopressa represents another important manufacturing achievement for Aerie in 2020,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “What began as a vision to control our destiny from a manufacturing standpoint in 2015 has led to the FDA approval of our facility earlier this year to produce Rocklatan, and now Rhopressa, for commercial distribution in the United States. We started shipping Rocklatan to the United States earlier in the third quarter of 2020 and have also manufactured supplies of Rhopressa for our upcoming phase 3 clinical trials in Japan. Additionally, we expect to begin shipping Rhopressa to the United States in the fourth quarter of 2020 as we continue to work towards the goal of having our Athlone facility supply our ophthalmic products for all markets in which we plan to operate.”