The FDA has approved a facility in Athlone, Ireland, for production of Rocklatan for the U.S. market, Aerie Pharmaceuticals announced in a press release.
Rocklatan (netarsudil and latanoprost ophthalmic solution 0.02%/0.005%) is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension.
The production plant’s clearance comes after a preapproval inspection of the facility and a review of a new drug application prior approval supplement, which added the facility as a product manufacturing location for the drug.
“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,” Vicente Anido Jr., PhD, chairman and CEO of Aerie, said in the release. “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 [prior approval supplement] 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.”