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Two Months Ahead of Schedule, FDA Clears Aerie Glaucoma Drug

Xconomy New York — 

The FDA has just approved a new medicine for glaucoma, a leading cause of blindness that affects close to 3 million Americans. Now the question is how eye doctors will use the drug, a treatment from Aerie Pharmaceuticals known as netarsudil (Rhopressa), and whether payers will cover the treatment.

In a statement late Monday, Aerie (NASDAQ: AERI), of Irvine, CA, and Bedminster, NJ, said the FDA approved netarsudil, an eye drop taken once a day at night, for people with open-angle glaucoma or ocular hypertension.

An Aerie spokesperson said via e-mail that the company “expects to price [netarsudil]…consistent with other branded glaucoma drops.” In the past, the company has stated that it expects a list price for netarsudil of at least $100 per month, net of rebates and other discounts, the spokesperson said.

Aerie isn’t providing any other details as of yet.

Glaucoma is a chronic disease that affects some 2.7 million people in the U.S.—a figure expected to climb to 4.3 million by 2030, according to the National Eye Institute—and open-angle glaucoma is the most common form. The disease is essentially a plumbing problem for the eye. Its drainage systems get clogged with fluid, which in turn puts pressure on and damages the optic nerve. If the pressure isn’t relieved, patients can lose their vision.

There is no cure for glaucoma, but there are a number of types of eye drops—prostaglandin analogues (PGAs), beta blockers and more—that patients can take every day, for the rest of their lives, to keep their eye pressure levels in check. PGAs have been the standard of care for glaucoma for more than a decade, and many of them are generic, cheap, and very effective. But PGAs also irritate the eyes and can change the color of peoples’ pupils, among other issues. Many patients move on to other treatments.

Netarsudil is meant to provide an alternative option. It works differently than other approved glaucoma drugs, impacting the eye’s drainage systems from multiple angles, including its main drain, a mesh-like filter known as the trabecular meshwork—a target none of the PGAs like latanoprost (Xalatan), directly affect.

An FDA advisory panel voted overwhelmingly in favor of Aerie’s drug in October, and the agency approved it two months ahead of schedule—it had been expected to make a decision by Feb. 28. But despite those endorsements, netarsudil’s commercial prospects are less clear for a few reasons. For one, aside from the other glaucoma therapies available, new ones are emerging. In November, the FDA approved a glaucoma drug from Valeant Pharmaceuticals (NYSE: VRX), Vyzulta, that adds a nitric oxide component to latanoprost to boost its effects. Plus, Aerie is developing a drug called Roclatan that combines netarsudil with latanoprost and is more effective than netarsudil alone—it aims to file for FDA approval of that drug next year. Third, netarsudil has been associated with some side effects, most notably eye redness (reported in 53 percent of patients). Other side effects include brown or grey deposits in the cornea (what’s known as corneal verticillata), and leaky blood vessels in the eye. Aerie has said most of these cases were mild to moderate, but it’s worth watching whether, commercially, side effects limit how long patients stay on treatment—and whether payers make it difficult to access the drug given the other available options (latanoprost, for instance, did a better job of lowering eye pressure than netarsudil in a study Aerie completed earlier this year).

Aerie expects to begin selling the drug by the mid-second quarter of 2018. CEO Vicente Anido Jr. said in a statement that the company hopes “to make strides” in getting formulary coverage for commercial plans in 2018, and to get a “formulary presence” for Medicare patients beginning in January 2019. Commercial plans and Medicare each cover about half of the U.S. patients with glaucoma, Anido Jr. said.

Check out this story for more on Aerie and the field of glaucoma therapies.