Is Aerie’s Move Sustainable?

The trial achieved its primary efficacy endpoint demonstrating non-inferiority of Rhopressa compared to timolol, the most widely used comparator.

Some clinicians have been waiting for an IOP-lowering product that specifically targets the diseased tissue. However, currently no treatments in the market have this unique function.

Vicente Anido Jr., Ph.D., chairman and CEO of Aerie, commented on the study:

We are very impressed by these Rhopressa phase 3 results from the Rocket 2 study. This product has demonstrated great promise with its novel mechanisms of action, including its ability to target the diseased tissue responsible for elevated IOP in glaucoma. The clear success demonstrated in this clinical trial, combined with the preclinical research to date on the disease-modification potential of Rhopressa, represent key building blocks in driving Aerie toward becoming a major ophthalmic pharmaceutical company.

Dr. Anido continued:

We look forward to our Rocket 2 safety results expected at the end of 2015 or early 2016. Based on our previous discussions with the FDA, we expect to file our Rhopressa NDA in mid-2016.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye.

In Wednesday’s after-hours alone, nearly 2.2 million shares traded, setting up what looks to be an incredibly positive Thursday.

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Shares of Aerie closed Wednesday up 0.2% to $18.00, in its 52-week trading range of $8.84 to $35.89. In early trading indications Thursday shares were up 93% at $34.84. The stock has a consensus analyst price target of $32.86.

This basically puts the stock back up near its all-time high that was set back in April. Like many other companies in the health care industry, Aerie lives by the FDA’s sword — as seen by this move — and dies by the same sword, as seen back in April.