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they’ve got light-colored pupils; lashes can grow abnormally (Allergan turned this side-effect into a lash-growing drug called Latisse); fatty tissue around the eyes can dissipate.
While PGAs only impact a secondary drainage system, Rhopressa and Roclatan target the TM, the primary draining system, itself.
They do this by blocking two targets: rho kinase and norepinephrine transporter (NET). Blocking rho relaxes the cells in the TM, helping fluid pass through. Blocking NET slows fluid production. The drugs also reduce pressure in another ocular drain pipe, the episcleral vein. Roclatan has another added boost: it’s a combination of Rhopressa and latanoprost.
Aerie was spun out of the work of David Epstein and Eric Toone at Duke University in 2005 and raised $75 million in venture money from TPG Biotech, Alta Partners, and others.
Those VCs lured Anido to lead the company in July 2013. A year earlier, he’d sold another eye drug maker, Ista Pharmaceuticals, to Bausch + Lomb for $500 million. Aerie’s backers hoped his Wall Street cred would intrigue public investors, and the plan worked—Aerie went public just three months after Anido arrived, and raised around $70 million.
In October 2013, Aerie priced a tick lower than it hoped, at $10 per share instead of $12 to $14, but it’s been steadily climbing since. Shares closed at $28.93 apiece Monday, about three times its IPO price. Anido says most of Aerie’s backers have had “about five to six-times returns already, if not more.”
But Anido still must guide Aerie to the commercial finish line. That starts with Rhopressa. Anido says the first of the drug’s three phase 3 studies will read out in May, with the other two following later in the year. Then there’s Roclatan, which will enter late-stage testing later this year.
There are a few things to watch out for in the upcoming data. The first is durability. In early clinical trials, Rhopressa lowered eye pressure and kept it down for about a month. Anido says that skeptics “have tried to make a big deal” about the fact that Aerie’s previous rho kinase blocker wore off after a few weeks. Aerie no longer makes that version, but Rhopressa’s durability is being put to the test: All Phase 3 studies treat patients with Rhopressa for at least 90 days. In one of those studies, patients will be on drug for a year.
The data should also help determine where Rhopressa fits into current drug regimens. In previous trials, the drug hasn’t been as effective as PGAs for patients with high levels of eye pressure. But Rhopressa has bested PGAs in so-called “normal-tension” glaucoma patients, who have damaged optic nerves despite normal pressure levels. This is important, because a significant number of glaucoma patients are in this normal-tension group, Madonna says.
“I think it’s very important that you’d get more bang for your buck in patients who have normal pressure,” he says. “Maybe I would move [normal-tension patients] to Rhopressa first as opposed to latanoprost, or any of the PGAs.”
Anido says Aerie is targeting normal-tension patients, patients with light eyes who worry about their eye color changing from PGAs, and those who need other adjunctive therapies.
The side effects in Aerie’s upcoming data will also be crucial. The biggest concern so far is redness. Rhopressa causes redness in between 20 and 30 percent of patients, compared to 16 to 20 percent for PGAs, Anido says, although he adds in most cases the redness is mild and has only caused a few patients to drop out of Aerie’s studies.
Still, it’s worth watching, particularly with Roclatan, which uses two different mechanisms known to cause redness.
“That could be a major issue,” Madonna says. “[But Roclatan] to me sounds like a winner if the side effect profile is appropriate.”