FDA Clears Aerie’s Combo Glaucoma Drug, But Will it Sell?

Xconomy New York — 

The FDA late Tuesday approved a new type of glaucoma drug from Aerie Pharmaceuticals that, in clinical testing, beat the generic eye drops known as prostaglandin analogues (PGAs) that are typically prescribed to slow the progression of the disease.

Now Aerie (NASDAQ: AERI) will try to prove that the drug can overcome some of its tolerability issues and upend the treatment paradigm for glaucoma, a chronic condition affecting millions of Americans.

The FDA approved Rocklatan for patients with open-angle glaucoma or ocular hypertension. The drug, a combination of the most prescribed PGA, latanoprost (Xalatan), and netarsudil, the active ingredient in Aerie’s already approved glaucoma drug netarsudil (Rhopressa), is an eye drop taken once a day.

Aerie has not yet said how much it will charge for Rocklatan but a company spokesman said it is expected to be a “small premium” to Rhopressa, which has a net price of about $100 per bottle. It will start selling the drug in the U.S. in the second quarter. Aerie shares climbed about 9 percent in pre-market trading on Wednesday.

Glaucoma occurs when the eye’s drainage systems become clogged, which in turn puts pressure on and damages the optic nerve. The goal for a glaucoma drug is to lower that pressure and protect people from losing their vision. About 2.7 million people in the U.S. live with glaucoma, a figure expected to climb to 4.3 million by 2030, according to the National Eye Institute.

There is no cure for glaucoma, but there are a number of types of eye drops—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.

Aerie won FDA approval of netarsudil in 2017 and launched it in April 2018. That drug is meant to provide an alternative option for patients, as it works differently than other approved glaucoma drugs, impacting the eye’s drainage systems from multiple angles. It generated $24.2 million in 2018, though analysts expect the number to climb to about $120 million this year.

The expectations are higher for Rocklatan. Given that the drug may be stronger than PGAs, Aerie hopes it might be able to either replace PGAs or provide another option for those who don’t respond to them. But Rocklatan’s side effects are a concern. In clinical testing, about 59 percent of patients on Rocklatan reported hyperemia, or redness, more than those on netarsudil or latanoprost. Aerie has said that most of cases were mild, the problem didn’t worsen with more treatment, and only 5 percent of patients dropped out of the trials because of it. But there were other side effects associated with Rocklatan. Two—brown or grey deposits in the cornea (what’s known as corneal verticillata, 15 percent of patients tested), and leaky blood vessels in the eye (11 percent)—were mentioned on the drug’s prescribing information, or label. The drug’s tolerability in the real world will be critical to its potential commercial success, particularly given all the other treatment options available. And its presence might also eat into sales of netarsudil.

“The prospects for first-line uptake and Rhopressa cannibalization remain outstanding questions from investors,” wrote Stifel analyst Annabel Samimy in a recent research note. “But we think that physicians are increasingly trending to using the most aggressive treatment upfront given the potential to stem the progression and fibrosis in glaucoma.”

Here’s more on Aerie, Rocklatan, and glaucoma.