DURHAM, NC, USA I December 03, 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 that it has submitted the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% with the European Medicines Agency (EMA). Should the MAA for Roclanda® be accepted for review by the EMA, an opinion from the Committee for Medicinal Products for Human Use is expected in approximately 12 months. Roclanda® is currently marketed in the United States as Rocklatan®.
The MAA submission for Roclanda® was predicated on the receipt of a marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%, which the European Commission granted in November 2019. Rhokiinsa® is marketed as Rhopressa® in the United States.
“Our regulatory team and other internal support groups worked tirelessly to complete the Roclanda® MAA filing so quickly after the receipt of the Rhokiinsa® marketing authorisation,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “In Europe, fixed-dose combinations with prostaglandins are frequently prescribed for the reduction of intraocular pressure associated with glaucoma. If approved, the combination of our Rho kinase inhibitor with a prostaglandin would be a first for Europe, and we look forward to working with the EMA in the coming months with the goal of bringing this potential new treatment to patients. As EMA review of the Roclanda® MAA begins, we will be completing and analyzing our Mercury 3 study, which compares Roclanda® to the leading fixed-dose combination product in the European Union. We expect results from this study will be reported next year, which should support our pricing and reimbursement activities.”
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, was 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
Post Views: 31
DURHAM, NC, USA I December 03, 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 that it has submitted the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% with the European Medicines Agency (EMA). Should the MAA for Roclanda® be accepted for review by the EMA, an opinion from the Committee for Medicinal Products for Human Use is expected in approximately 12 months. Roclanda® is currently marketed in the United States as Rocklatan®.
The MAA submission for Roclanda® was predicated on the receipt of a marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02%, which the European Commission granted in November 2019. Rhokiinsa® is marketed as Rhopressa® in the United States.
“Our regulatory team and other internal support groups worked tirelessly to complete the Roclanda® MAA filing so quickly after the receipt of the Rhokiinsa® marketing authorisation,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “In Europe, fixed-dose combinations with prostaglandins are frequently prescribed for the reduction of intraocular pressure associated with glaucoma. If approved, the combination of our Rho kinase inhibitor with a prostaglandin would be a first for Europe, and we look forward to working with the EMA in the coming months with the goal of bringing this potential new treatment to patients. As EMA review of the Roclanda® MAA begins, we will be completing and analyzing our Mercury 3 study, which compares Roclanda® to the leading fixed-dose combination product in the European Union. We expect results from this study will be reported next year, which should support our pricing and reimbursement activities.”
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, was 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
Post Views: 31
