Aerie Pharmaceuticals, Inc, an ophthalmic pharmaceutical company, said on Tuesday its sterile fill production facility in Athlone, Ireland received approval from the U.S. Food and Drug Administration (FDA) for production of Rhopressa to be distributed commercially in the U.S.
The approval follows the FDA’s review of the New Drug Application Prior Approval Supplement (PAS), which included the Athlone facility as a manufacturer for Rhopressa, a prescription eye medication used for open-angle glaucoma or ocular hypertension.
In a statement, Aerie’s CEO Vicente Anido, Jr. called the approval “another important manufacturing achievement” for the company.
“What began as a vision to control our destiny from a manufacturing standpoint in 2015 has led to the FDA approval of our facility earlier this year to produce Rocklatan, and now Rhopressa, for commercial distribution in the United States,” Anido said in a statement.
Anido said the company expects to start shipping Rhopressa to the U.S. in the fourth quarter as the company works toward having its Athlone production facility supply its ophthalmic products across the markets it plans to operate.
Aerie began shipping Rocklatan, another produced intended for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, to the U.S. in the third quarter. The company also manufactured supplies of Rhopressa for its upcoming Phase 3 clinical trials in Japan.
Shares of Aerie Pharmaceutical were last trading up 4.56 percent, or 51 cents higher, near $11.63 on Tuesday.