Amakem Presents Glaucoma Data

Amakem Therapeutics has presented top-line results from two studies for AMA0076 for the treatment of glaucoma at the Ophthalmology Innovation Summit (OIS) at the 2013 Annual Meeting of the American Academy of Ophthalmology. The results detailed a first-in-human study in patients with glaucoma and ocular hypertension and a Phase Ib formulation study in healthy volunteers.

AMA0076 is a highly potent locally-acting Rho Kinase (ROCK) inhibitor that has been designed to reduce intraocular pressure (IOP) while minimizing side effects such as hyperemia that have been observed with other ROCK inhibitors so far tested clinically. Hyperemia as observed with all other ROCK inhibitors in development is a particularly problematic side effect leading to patient non-compliance.

The first-in-human study was a multicenter, randomized, double-masked, placebo-controlled dose-escalation study with AMA0076 applied topically, as eye drops. At the most effective dose, IOP reduction from baseline (the primary endpoint of the study) was evident across visits, diurnal time points and both eyes while no conjunctival hyperemia related adverse events were observed. At the end of treatment, this dose group achieved a decrease in mean diurnal IOP from baseline of 3.7 mmHg.

Additional work has demonstrated that AMA0076’s bioavailability could be further increased and Amakem has conducted a Phase Ib study with several new formulations of AMA0076, all with significantly improved corneal absorption. The optimized formulation led to substantial IOP reduction with no significant hyperemia.