DURHAM, NC, USA I November 21, 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 Commission (EC) has granted a marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension.
The marketing authorisation application (MAA) for Rhokiinsa® was accepted for review by the European Medicines Agency (EMA) in October 2018. Aerie received a positive scientific opinion recommending approval of the Rhokiinsa® MAA from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in September 2019.
“The receipt of an EC marketing authorisation for Rhokiinsa® is an important milestone for Aerie as it once again demonstrates the potential value of Aerie’s netarsudil franchise at an international level,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “Importantly, this approval also sets the stage for our filing of an MAA for Roclanda® with the EMA by early 2020 and we would expect that review process would take approximately one year. In the interim, we look forward to our Rocklatan®, known as Roclanda® in Europe, Mercury 3 data expected by mid-2020. These data will help set the stage for our commercialization strategy in Europe.”
Rhokiinsa® was approved by the U.S. Food and Drug Administration (FDA) in December 2017 under the trade name Rhopressa® for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Roclanda® was approved by the FDA in March 2017 under the trade name Rocklatan® for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The marketing authorisation is valid in all 28 countries of the European Union, plus Iceland, Norway and Liechtenstein.
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: 19
DURHAM, NC, USA I November 21, 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 Commission (EC) has granted a marketing authorisation for Rhokiinsa® (netarsudil ophthalmic solution) 0.02% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension.
The marketing authorisation application (MAA) for Rhokiinsa® was accepted for review by the European Medicines Agency (EMA) in October 2018. Aerie received a positive scientific opinion recommending approval of the Rhokiinsa® MAA from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in September 2019.
“The receipt of an EC marketing authorisation for Rhokiinsa® is an important milestone for Aerie as it once again demonstrates the potential value of Aerie’s netarsudil franchise at an international level,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “Importantly, this approval also sets the stage for our filing of an MAA for Roclanda® with the EMA by early 2020 and we would expect that review process would take approximately one year. In the interim, we look forward to our Rocklatan®, known as Roclanda® in Europe, Mercury 3 data expected by mid-2020. These data will help set the stage for our commercialization strategy in Europe.”
Rhokiinsa® was approved by the U.S. Food and Drug Administration (FDA) in December 2017 under the trade name Rhopressa® for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Roclanda® was approved by the FDA in March 2017 under the trade name Rocklatan® for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The marketing authorisation is valid in all 28 countries of the European Union, plus Iceland, Norway and Liechtenstein.
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: 19
