Based on the company’s Localized Drug Action platform, AMA0076 is a highly potent locally-acting Rho Kinase (ROCK) inhibitor designed to reduce intraocular pressure (IOP) by acting specifically on the main outflow system in the eye while minimising side effects such as hyperemia (red eye).
Around 80 patients in the US are expected to be enrolled in the Phase II trial with an optimized formulation of AMA0076 applied topically as eye-drops.
Primary efficacy endpoint of the trial will be change in IOP from baseline at the end of 28 days of treatment, while secondary endpoints include IOP assessment at other time points as well a safety and tolerability assessments.
Earlier, AMA0076 demonstrated IOP reduction without significant hyperemia in a first-in-human trial in patients with glaucoma and ocular hypertension.
Amakem chief executive officer Jack Elands said AMA0076 has showed IOP reduction without significant hyperemia, the first ROCK inhibitor to achieve this goal in the clinic.
"The experience we gained in our first-in-human study and the subsequent clinical evaluation of our new formulation gives us great confidence as we begin this dose-ranging study," Elands said.
The company plans to report top line results from the multicenter, randomised, double-masked, placebo-controlled trial in the fourth quarter of 2014.