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Harvey Dubiner, Brian Levy, Casey Kopczynski, Gary D Novack; Double-masked, randomized, dose-response study of AR-13324 Ophthalmic Solution compared to latanoprost in patients with elevated intraocular pressure. Invest. Ophthalmol. Vis. Sci. 2014;55(13):545.
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AR-13324 is in a new class of agents that inhibit both Rho kinase and norepinephrine transporter to increase trabecular outflow and decrease aqueous production. We evaluated two concentrations of AR-13324 compared to latanoprost for their ocular hypotensive efficacy and ocular and systemic safety.
Adult patients (N=224) with open-angle glaucoma or ocular hypertension were randomized to receive either AR-13324 0.01% or 0.02% q.d. or latanoprost q.d. for 28 days, q.d. (PM).
Mean unmedicated diurnal IOP was 25 to 26 mm Hg across groups. On Day 28, in the mITT population of 221, mean diurnal IOP was 20.1, 20.0 and 18.7 mm Hg for the AR-13324 0.01%, 0.02% and latanoprost groups, respectively, representing a decrease from baseline of 5.5, 5.7 and 6.8 mm Hg (p < 0.0001).In a planned subgroup analysis of patients with baseline IOP’s <=26 mmHg (N=106), the decrease from baseline in each group on Day 28 was 5.4, 5.8 and 6.0 mm Hg, respectively (p < 0.0001). The difference in the change from baseline between AR 13324 0.02% and latanoprost was 1.2 mm Hg (p=0.009) in the mITT population compared to 0.2 mm Hg in the subgroup with baseline IOPs <= 26 mmHg (p=0.754). These results show that AR-13324 0.02% maintained similar efficacy regardless of baseline IOP, whereas latanoprost was less effective at baseline IOPs <= 26 mmHg. The only drug-related safety finding of note for AR-13324 was conjunctival hyperemia, which was typically scored as mild to moderate and appeared to diminish throughout the study. On Day 28, 08:00 hours, the incidence of mild to moderate conjunctival hyperemia on biomicroscopic examination was 18%, 24% and 11%, respectively.
AR-13324 0.01% and 0.02% produced clinically and statistically significant reductions in IOP. On Day 28, 0.02% AR-13324 was approximately 1 mm Hg less effective than latanoprost in patients with unmedicated IOPs in the range of 22 - 36 mm Hg. However, AR 13324 0.02% had equivalent efficacy to latanoprost (within 0.2 mm Hg) in patients with baseline IOPs of 22 - 26 mm Hg. The only drug-related adverse event of note was conjunctival hyperemia which for the majority of patients was mild to moderate and transient. : AR-13324 was an effective ocular hypotensive agent and well tolerated in patients with glaucoma and ocular hypertension.
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