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Aerie Reports Positive Results In Phase 2a Study For AR-12286

PBR Staff Writer Published 22 October 2009

Company to initiate phase 2b study soon

Aerie Pharmaceuticals (Aerie) has reported positive results from a phase 2a study of its Rho-kinase (ROCK) inhibitor, AR-12286. The study evaluated the safety, tolerability and efficacy of three different doses of AR-12286 in 88 patients with primary open angle glaucoma or ocular hypertension.

The study results suggested that AR-12286 was safe and well-tolerated. In addition, the phase 2a study achieved statistical significance in demonstrating lowered intraocular pressure (IOP) with both once-daily and twice-daily treatment.

AR-12286 has achieved a maximum change of mean IOP of 28% from baseline, which is comparable to, or exceeds, pressure lowering attained by the most commonly used glaucoma drugs, as reported in other studies.

Reportedly, the phase 2a study was a multi-center, randomised, double-masked, placebo-controlled study in which patients were randomly assigned to receive one of three doses of AR-12286 or placebo. Patients were first dosed once daily and then twice daily and evaluated over a three-week treatment period.

Thomas van Haarlem, president and CEO of Aerie, said: “We are very pleased with these results and will soon initiate a phase 2b study with once-daily dosing in a larger patient group in order to determine the optimal dose to take forward into phase 3 registration studies. Aerie’s goal is to advance the quality of glaucoma care and the clinical success of AR-12286 represents a significant step. We have several other innovative R&D programs underway with significant therapeutic potential, including the recent discovery by Aerie scientists of a new class of dual-action glaucoma drugs.”

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