Aerie Pharmaceuticals Submits Prior Approval Supplement to FDA to Allow Production of Rocklatan in its Athlone Ireland Facility

Aerie Pharmaceuticals announced the submission of a prior approval supplement (PAS) to the FDA to 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,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer, said in a company news release. “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 pre-approval 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.