European Commission Decision Anticipated In Approximately Two Months

DURHAM, NC, USA I September 20, 2019 I 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 European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorisation application (MAA) for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%. The recommended indication is the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension.

The CHMP positive opinion is a scientific recommendation for marketing authorisation referred to the European Commission for a final decision on the Company’s MAA. The final decision is expected in approximately two months and will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein.

“We are delighted that the CHMP has adopted a positive opinion for Rhokiinsa®,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We look forward to the European Commission’s final decision on the MAA for Rhokiinsa® and, if approved, we plan to submit the MAA for Roclanda®, marketed as Rocklatan® in the United States, shortly thereafter.”

Rhokiinsa® is currently marketed as Rhopressa® in the United States and is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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, retinal diseases and other diseases of the eye. 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, has been approved by the FDA and was launched in the United States in the second quarter of 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.

SOURCE: Aerie Pharmaceuticals