Aerie Pharmaceuticals announced that its sterile fill production facility in Athlone, Ireland has received approval from FDA to produce Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the U.S. market. The regulatory clearance of the plant follows a successful preapproval inspection of the facility and FDA review of the new drug application prior approval supplement (PAS), which added the Athlone production facility as a drug product manufacturer for Rocklatan.
“I want to personally thank each and every employee for a job very well done. This is a very proud moment for our company, the culmination of a dream we first had in 2015 to better control our own destiny from a manufacturing standpoint,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “It is certainly not every day that a new, state-of-the-art pharmaceutical production facility comes on line, a career-high achievement for every member of the Athlone team and the Aerie departments that supported their work. Their accomplishment is even more remarkable because of the project’s highly accelerated timeline. Design and construction of this facility was only initiated in 2017, in an empty building shell, but by early 2019 the facility had successfully completed Rocklatan process validation batches, enabling our PAS to be submitted with the FDA in September. We aim to have Rhopressa produced in Athlone later in 2020, and eventually, we anticipate that Athlone will supply our ophthalmic products for all the markets in which we will operate.”