Product Approved Ahead of the Scheduled PDUFA Date of February 28, 2018
IRVINE, CA, USA I December 18, 2017 I Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), 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 and other diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved Rhopressa® (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. A link to the full product label is available on the Aerie website at http://investors.aeriepharma.com. The FDA approval decision was made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018.
“The approval of once-daily Rhopressa® represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians. It is a testament to years of successful research and development and the incredible talents of our dedicated employees, to whom we owe much gratitude. We have been preparing for commercialization for well over a year, and our plans are clear. We will hire our sales force of 100 sales representatives early in the first quarter of 2018, and plan to launch by mid-second quarter of 2018. As the 2018 year progresses, it is our goal to make strides in gaining formulary coverage for commercial plans, which represent approximately half of the U.S. market. The other half of the U.S. market is covered through Medicare Part D, and we expect our formulary presence for this market to commence in January 2019. We also remain on track to file our Roclatan™ new drug application to the FDA in second quarter 2018,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “As we reflect on the Rhopressa® approval, we pay tribute to Aerie’s late co-founder, Dr. David Epstein. He was a visionary in the field of glaucoma and always believed in the potential IOP-lowering benefits of Rho kinase inhibition. This is a fulfillment of his dream.”
About Rhopressa®
Rhopressa® (netarsudil ophthalmic solution) 0.02%, is a novel once-daily eye drop for the lowering of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, and was approved by the FDA in December 2017. Rhopressa® is believed to reduce IOP by increasing the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye. A link to the full product label is available on the Aerie web site at http://investors.aeriepharma.com.
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 glaucoma and other diseases of the eye. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, was approved by the U.S. Food and Drug Administration (FDA) in December 2017. Aerie’s second product candidate, Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa® and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. The Roclatan™ NDA submission is expected to take place in the second quarter of 2018. Aerie is also focused on global expansion and the development of additional product candidates and technologies in ophthalmology.
SOURCE: Aerie Pharmaceuticals
Post Views: 55
Product Approved Ahead of the Scheduled PDUFA Date of February 28, 2018
IRVINE, CA, USA I December 18, 2017 I Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), 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 and other diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved Rhopressa® (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. A link to the full product label is available on the Aerie website at http://investors.aeriepharma.com. The FDA approval decision was made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018.
“The approval of once-daily Rhopressa® represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians. It is a testament to years of successful research and development and the incredible talents of our dedicated employees, to whom we owe much gratitude. We have been preparing for commercialization for well over a year, and our plans are clear. We will hire our sales force of 100 sales representatives early in the first quarter of 2018, and plan to launch by mid-second quarter of 2018. As the 2018 year progresses, it is our goal to make strides in gaining formulary coverage for commercial plans, which represent approximately half of the U.S. market. The other half of the U.S. market is covered through Medicare Part D, and we expect our formulary presence for this market to commence in January 2019. We also remain on track to file our Roclatan™ new drug application to the FDA in second quarter 2018,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “As we reflect on the Rhopressa® approval, we pay tribute to Aerie’s late co-founder, Dr. David Epstein. He was a visionary in the field of glaucoma and always believed in the potential IOP-lowering benefits of Rho kinase inhibition. This is a fulfillment of his dream.”
About Rhopressa®
Rhopressa® (netarsudil ophthalmic solution) 0.02%, is a novel once-daily eye drop for the lowering of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, and was approved by the FDA in December 2017. Rhopressa® is believed to reduce IOP by increasing the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye. A link to the full product label is available on the Aerie web site at http://investors.aeriepharma.com.
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 glaucoma and other diseases of the eye. Aerie’s first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, was approved by the U.S. Food and Drug Administration (FDA) in December 2017. Aerie’s second product candidate, Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa® and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. The Roclatan™ NDA submission is expected to take place in the second quarter of 2018. Aerie is also focused on global expansion and the development of additional product candidates and technologies in ophthalmology.
SOURCE: Aerie Pharmaceuticals
Post Views: 55
