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Harvey Dubiner, Brian Levy, Nancy Ramirez, Casey Kopczynski, Gary D Novack, ; Fixed dose combination of AR-13324 and latanoprost (PG324): A double-masked, randomized, controlled study in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5704.
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PG324 Ophthalmic Solution in a fixed dose combination of AR-13324, a new ocular hypotensive drug that inhibits both Rho kinase and the norepinephrine transporter, and latanoprost, a prostaglandin FP receptor agonist. We evaluated 4 treatments: PG324 0.01% and 0.02%, AR-13324 0.02% and Latanoprost Ophthalmic Solution 0.005%, all q.d., PM.
At 23 centers, patients with OAG or OHT received a complete eye examination and underwent washout as required. Qualified patients (unmedicated IOP ≥ 24 mm Hg at 08:00 hours) were randomized to one of the four treatments which they instilled for 28 days. The primary outcome was mean diurnal IOP at Day 29.
In the 298 patients, mean unmedicated diurnal IOP (average of all measurements on Day 1, prior to study medication) was 25.1, 25.1, 26.0 and 25.4 in the PG324 0.01%, PG324 0.02%, latanoprost and AR-13324 0.02% groups, respectively. On Day 29, PG324 0.01% and PG324 0.02% demonstrated statistical superiority in mean diurnal IOP relative to latanoprost (p=0.0071 and p <0.0001, respectively) and AR-13324 0.02% (p=0.0002 and p < 0.0001), with mean diurnal IOP decreased to 17.3, 16.5, 18.4, and 19.1 mm Hg, respectively. PG324 0.02% also demonstrated superiority in mean IOP relative to latanoprost and AR-13324 0.02%, with PG324 achieving IOPs that were 1.6-3.2 mm Hg lower than latanoprost (p <0.05). The most frequently reported adverse event was conjunctival hyperemia with an incidence of 41% (30/73), 40% (29/73), 14% (10/73) and 40% (31/78), respectively.
The fixed-dose combination of AR-13324 0.02% and latanoprost 0.005% in PG324 Ophthalmic Solution provides clinically and statistically superior ocular hypotensive efficacy relative to its individual active components. Both concentrations of PG324 were well tolerated. For the most part, the events were mild and transient. Note that the addition of latanoprost to AR-13324 in PG324 did not seem to increase the incidence of conjunctival hyperemia beyond that of AR-13324 alone. The only safety finding of note was transient, self-limiting conjunctival hyperemia which for the majority of patients was of trace or mild severity
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