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Pilot Clinical Trial Indicates Glaucoma Drug Efficacy

Eyes closeup (Paleontour/Flickr)Results from a pilot clinical trial suggests a drug made by Aerie Pharmaceuticals of Bedminister, New Jersey is effective at treating glaucoma. The phase 2a trial tested Aerie’s candidate AR-13324 with 80 patients at 11 locations in the U.S. between March and July 2012.

The patients enrolled in the double-blinded trial had open angle glaucoma, the most common form of glaucoma, or higher than normal intraocular pressure known as ocular hypertension. Open angle glaucoma occurs when the the flow of acqueous humor fluid in the eye is blocked causing intraocular pressure to build past the point where it causes damage to the optic nerve.

The study tested the safety and tolerability of AR-13324 as well as its efficacy. AR-13324 simultaneously lowers intraocular pressure by enhancing fluid outflow, while decreasing fluid inflow to the eye.

In the study, patients received one of three dosage levels of AR-13324 — 0.01, 0.02, or 0.04 percent — or a placebo. Patients received the drug once a day in the morning for seven days and were evaluated at four different time points during the day. The findings show patients taking the drug had lower intraocular pressure than patients taking the placebo. In addition, the patients testing the drug maintain those reductions over 24 hours.

Patients in the 0.02 percent group achieved the greatest response during the treatment period. Aerie says the drug was well tolerated by patients in the trial. Mild to moderate eye redness was observed after the first dose and appeared to diminish by the end of the treatment period.

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Photo: Paleontour/Flickr

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