Aerie Pharma's 2nd Glaucoma Drug Gets FDA Approval
The U.S. Food and Drug Administration (FDA) approved Aerie Pharmaceuticals Rocklatan (netarsudil and latanoprost ophthalmic solution) to decrease elevated intraocular pressure (IOP) in open-angle glaucoma or ocular hypertension.
The eye drops were developed as a once-daily treatment. It combines netarsudil, which is the active ingredient in its approved product Rhopressa, with latanoprost, a prostaglandin analog (PGA) that is the most commonly prescribed drug for lowering IOP. It is the first fixed-dose combination drug containing a PGA in the U.S.
The submission was based on data from two U.S. pivotal Phase III trials, MERCURY 1 and 2, which suggested the combination drug had the potential to provide greater IOP-lowering than the most common drugs for glaucoma.
In the trials, Rocklatan met the primary 90-day efficacy endpoint in addition to positive 12-month safety and efficacy data. Rocklatan showed statistically superior IOP decrease over latanoprost and netarsudil at every measured period. Of the patients receiving Rocklatan, more than 60 percent achieved an IOP reduction of 30 percent or more, nearly twice the frequency by the latanoprost cohort.
Rhopressa was approved by the FDA in February 2018 and launched in April 2018. At the company’s fourth-quarter report on February 25, Vicente Anido, Jr., chairman and chief executive officer, stated, “We are delighted to have achieved the revenue guidance that we announced a full year ago, well before Rhopressa launched in the United States. With Rhopressa net sales having doubled from third-quarter to fourth-quarter 2018, and our significant progress in gaining market access, we are confident in the continued meaningful growth prospects for this very well-received product.”
Glaucoma is typically caused by a buildup of pressure inside the eye. It is generally inherited and doesn’t usually show up until later in life. The increased pressure is called intraocular pressure and can damage the optic nerve. If that damage goes unchecked, it can lead to permanent vision loss. There are no particular early symptoms or pain. Eye doctors typically run an eye pressure test as part of a routine optical exam.
The disease affects at least 60 million people globally and the National Eye Institute estimates more than 2.7 million people in the U.S. have the disease. That number is expected to hit 4.3 million by 2030. It is also highly undiagnosed. The Eye Diseases Prevalence Research Group estimates that only half of individuals in the U.S. with glaucoma are aware they have it. As a result, it is a leading cause of adult blindness, but one of the most preventable with diagnosis and effective treatment.
Aerie indicates it plans to launch Rocklatan in the U.S. in the second quarter of 2019.
“We are in a unique position of receiving FDA approval on a second glaucoma treatment less than a year from the U.S. launch of Rhopressa,” stated Anido. “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. Our existing salesforce, which has been calling on U.S. eye-care professionals since last May, is very well positioned to introduce Rocklatan to these doctors and help them understand the clinical utility of both products in the care of their patients with glaucoma.”