FDA Approves Aerie’s Newest Glaucoma Therapy
Durham-based Aerie Pharmaceuticals, a developer of therapies for eye diseases, has received approval from the U.S. Food and Drug Administration (FDA) to begin selling Rocklatan, a once-daily eye drop for reducing high intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Rocklatan is a combination of latanoprost, the most widely prescribed prostaglandin analog, and netarsudil, the active ingredient in Rhopressa, Aerie’s first-in-class Rho kinase (ROCK) inhibitor that targets the trabecular meshwork, the eye’s principal drainage pathway for fluids. A diseased trabecular meshwork is considered to be the main cause of elevated intraocular pressure in open-angle glaucoma and ocular hypertension.
Rhopressa, Aerie’s first FDA-approved product, works by restoring fluid outflow through the trabecular meshwork, while latanoprost increases outflow through a secondary mechanism, the uveoscleral pathway.
Aerie launched Rhopressa in the United States in April 2018 and plans to launch Rocklatan in the second quarter of this year.
“We are in the unique position of receiving FDA approval on a second glaucoma treatment less than a year from the U.S. launch of Rhopressa,” said Vicente Anido, Jr., Ph.D., chairman and chief executive officer at Aerie. “Together, Rocklatan and Rhopressa give us a broad therapeutic franchise, based on our ROCK inhibitor, netarsudil, that addresses many of the needs of clinicians and patients in a wide variety of treatment settings.”
Anido said the company’s salesforce is well positioned to introduce Rocklatan to doctors and help them understand the clinical utility of both products in the care of their glaucoma patients.
“We have also been working diligently on securing favorable reimbursement for our products, with Rhopressa now enjoying broad commercial and Medicare Part D coverage, and Rocklatan™ already under review by major payers,” he said.
The FDA’s approval of Rocklatan is based on data from two Phase 3 registration trials, MERCURY 1 and MERCURY 2. In these studies, Rocklatan achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior reduction of intraocular pressure over latanoprost and netarsudil.
More than 60 percent of patients taking Rocklatan in the two MERCURY studies had reduced intraocular pressure of 30 percent or more, nearly twice that achieved by participants taking latanoprost alone. Rocklatan also helped more patients get to low target pressures.
Glaucoma on the rise
Glaucoma is a disease that causes damage to the optic nerve. It is characterized by progressive degeneration of retinal cells, resulting in irreversible vision loss and, potentially, blindness.
At least 60 million people worldwide are thought to be affected by glaucoma, a disease associated with aging. The National Eye Institute estimates that more than 2.7 million people in the United States suffer from glaucoma and that 4.3 million will have the disease by 2030.
The Eye Diseases Prevalence Research Group has estimated that only half of Americans with glaucoma know they have the disease. As a result, glaucoma remains a leading cause of adult blindness.
With diagnosis and effective treatment, however, glaucoma is also one of the most preventable eye diseases.
A Duke spinout
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.
The company is a spinout of Duke University based on the glaucoma research of the late David L. Epstein, M.D., a clinician and scientist who chaired the Department of Ophthalmology at Duke’s School of Medicine for 22 years.
Aerie has about 365 employees at its sites in Durham, Irvine, Calif., Bedminster, N.J., Tokyo, Henley-on-Thames, England, and Dublin. It has a manufacturing plant in Athlone, Ireland, that is under construction and is scheduled to come online in 2020.
The Durham headquarters has 77 employees and is adding more.
Aerie became a publicly traded company in 2013, and its stock shares are traded on the NASDAQ Global Market stock exchange under the symbol AERI.