Diepenbeek, Belgium—Amakem NV has initiated a phase IIa proof of concept study of its novel rho-kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension.
The company, a kinase platform company focusing on ophthalmology, recently received Investigational New Drug Application (IND) approval from the FDA.
AMA0076 is a highly potent ROCK inhibitor and is based on Amakem’s “Localized Drug Action” platform, which generates novel kinase inhibitors that minimize the risk of systemic as well as local side effects, such as hyperemia.
The first patients have been enrolled in the multicenter, randomized, double-masked, placebo-controlled dose-escalation study, which will be conducted at six centers in the United States.
AMA0076 is applied topically, as eye drops, and the primary efficacy endpoint will be reduction in IOP after 2 and 4 weeks of dosing.
AMA0076 is aimed at providing better patient outcomes than other ROCK inhibitor-based treatments currently in development because its improved side effect profile enables higher dosing, leading to better efficacy, according to the company.
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