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Aerie Pharmaceuticals Announces U.S. Food and Drug Administration Approval of its Athlone, Ireland Facility for Production of Rhopressa (netarsudil ophthalmic solution) 0.02%

Nachrichtenquelle: Business Wire (engl.)
15.09.2020, 12:45  |  104   |   |   

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, ocular surface diseases and retinal diseases, today announced that its sterile fill production facility in Athlone, Ireland has received approval from the U.S. Food and Drug Administration (FDA) for production of Rhopressa (netarsudil ophthalmic solution) 0.02% for commercial distribution in the United States. This approval comes following the FDA review of the New Drug Application Prior Approval Supplement (PAS), which added the Athlone production facility as a drug product manufacturer for Rhopressa.

“The PAS approval for Rhopressa represents another important manufacturing achievement for Aerie in 2020,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “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. We started shipping Rocklatan to the United States earlier in the third quarter of 2020 and have also manufactured supplies of Rhopressa for our upcoming Phase 3 clinical trials in Japan. Additionally, we expect to begin shipping Rhopressa to the United States in the fourth quarter of 2020 as we continue to work towards the goal of having our Athlone facility supply our ophthalmic products for all markets in which we plan to operate.”

About Aerie Pharmaceuticals, Inc.

Aerie is 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, ocular surface diseases and retinal diseases. Aerie’s first product, Rhopressa (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa, including the product label, is available at www.rhopressa.com. Aerie’s second product for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension, Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa and the widely-prescribed PGA (prostaglandin analog) latanoprost, was launched in the United States in May 2019. In clinical trials of Rocklatan, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan, including the product label, is available at www.rocklatan.com. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.

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Aerie Pharmaceuticals Announces U.S. Food and Drug Administration Approval of its Athlone, Ireland Facility for Production of Rhopressa (netarsudil ophthalmic solution) 0.02% 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, ocular surface diseases …

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