Aerie Pharmaceuticals has submitted a prior approval supplement (PAS) to the U.S. Food and Drug Administration (FDA), to be allowed to produce Rocklatan in Ireland, to be sold USA.
DURHAM, N.C.–(BUSINESS WIRE)–Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye today announced the submission of a prior approval supplement (PAS) to the U.S. Food and Drug Administration (FDA). If approved, the PAS will permit production of Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for sale in the United States in Aerie’s new manufacturing plant in Athlone, Ireland.
“Along with the successful GMP inspection and authorization of the Athlone plant for product manufacturing by Ireland’s Health Products Regulatory Authority (HPRA), we have also successfully executed process validation studies for Rocklatan® and generated stability data to support registration of the Athlone plant with the FDA,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “Our PAS submission is another milestone for Aerie as we continue to move towards having our state-of-the-art plant facilitate the global supply of Aerie products.”
Based on FDA timelines, Aerie expects the PAS filing review to be completed within 60 days, with final PAS review in 4 months. In addition, the Company anticipates a preapproval inspection of the Athlone manufacturing plant during the 4-month review. A successful inspection along with FDA approval of the supplement would allow Rocklatan® to be manufactured in Athlone for sale in the United States in the first half of 2020. The Company also plans to file a PAS in the first half of 2020 to obtain FDA approval to manufacture Rhopressa® (netarsudil ophthalmic solution) 0.02% in Athlone.
Rocklatan® was approved by the FDA in the United States on March 12, 2019 and the commercial launch in the United States occurred on May 1, 2019.