Aerie seeks FDA approval to manufacture Rocklatan in Ireland
Aerie Pharmaceuticals has submitted a prior approval supplement to the FDA to allow Rocklatan production in its Athlone, Ireland, facility, according to a press release.
Rocklatan (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution) is indicated for the treatment of open-angle glaucoma or ocular hypertension.
“Along with the successful GMP inspection and authorization of the Athlone plant for product manufacturing by Ireland’s Health Products Regulatory Authority, 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, Aerie chairman and CEO, said in the release.
The company expects the filing review to be completed within 60 days, with final review in 4 months. If the supplement is approved by the FDA, Aerie would manufacture Rocklatan in Athlone for sale in the United States. There are also plans to seek approval to manufacture Rhopressa (netarsudil ophthalmic solution 0.02%) in Athlone.