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Focused on Glaucoma, Aerie Looks Toward Unblinding Critical Data

Xconomy New York — 

Glaucoma is a ripe opportunity for drug developers. Generics litter the field, yet it’s a roughly $5 billion market that will only grow with an aging population. What’s more, nothing out there cures the disease. Patients typically take eye drops, chronically, for the rest of their lives.

In other words, there’s room for innovation. That’s what led successful ophthalmology executive Vicente Anido Jr. to Bedminster, NJ-based Aerie Pharmaceuticals, one of the leading contenders with a new approach to the disorder.

By the end of the year, Aerie (NASDAQ: AERI) will report the results of three different Phase 3 trials for a drug called Rhopressa, an experimental glaucoma treatment. A late-stage study for a follow-up drug, Roclatan, should begin this year as well.

These trials will provide important information, like how well the drugs hold up over time, and how their side effects compare to other treatments. If successful, the trials could also signal that the standard of care for glaucoma, which has been stagnant for at least a decade, might be changing.

Competition is heating up in the glaucoma space, and for good reason: it’s a growing market. 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.

That market also happens to be dominated by a group of drugs, many of them generic, known as prostaglandin analogues (PGAs). Companies have crowded the field trying to one-up these PGAs in one way or another. Through its Bausch + Lomb subsidiary, for instance, Valeant Pharmaceuticals (NYSE: VRX) is expected to soon seek FDA approval of a drug that aims to make the most commonly prescribed PGA, known as latanoprost (Xalatan), more effective by adding a nitric oxide component. Bedford, MA-based Ocular Therapeutix (NASDAQ: OCUL) and Research Triangle Park, NC-based Envisia Therapeutics, among others, are developing ways to deliver PGAs into the eye over an extended period of time.

Others like Japan and Seattle-based Acucela and Inotek Pharmaceuticals (NASDAQ: ITEK) of Lexington, MA, are looking at different molecular targets for drugs that, at minimum, work in tandem with PGAs.

And then there’s Aerie, which is doing a little bit of everything. One drug (Rhopressa) is meant to be an adjunct therapy for PGAs or, in some cases, a replacement. The other drug (Roclatan), is meant to completely supplant PGAs and as Anido (pictured above) says, be a doctor’s “biggest gun” against glaucoma. Despite the competition, and the questions that Aerie still has to answer with data, experts are intrigued by its prospects.

“I think [Rhopressa] sounds really good,” says Richard Madonna, the chairman of clinical education, as well as a professor, at SUNY College of Optometry in New York, who isn’t involved with Aerie. “It’ll be very interesting if and when it does come to market.”

The reason: Aerie’s method is a return, of sorts, to the roots of glaucoma treatment. The first glaucoma drug was pilocarpine, or pilo, a drug derived from the jaborandi tree, a shrubby native of South and Central America and the West Indies.

Pilo directly solves a plumbing problem. That is, it relieves pressure that builds up when the trabecular meshwork (TM), a mesh-like filter that serves as the eye’s main fluid drainage system, gets clogged. When it does, aqueous humor, the gel-like fluid that shuttles nutrients through the eye, doesn’t drain properly. The excess fluid puts pressure on, and ultimately damages the optic nerve. If the pressure isn’t relieved, patients can gradually lose their vision.

While pilo relieves that pressure, it’s a very flawed drug and rarely used. It has to be taken four times a day, causes severe redness, and hampers peoples’ ability to focus.

Because of those faults, pilo gave way to so-called beta blockers like timolol, introduced in the late 70s, and later PGAs, once-a-day drops which arrived around the year 2000 and quickly became the standard of care for glaucoma.

Beta-blockers are now adjunctive therapies for people who don’t respond to PGAs (still a large market, as nearly half of U.S. glaucoma patients use a second therapy).

Like pilo, PGAs are no picnic. They irritate the eyes, causing redness; peoples’ eye color can change if … Next Page »

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