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Fixed-dose combination reduces IOP more than individual components at 1 month
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A fixed-dose combination of medications reduced IOP significantly more than the constituent components, with minimal side effects, a study found.
Investigators evaluated the ocular hypotensive efficacy of AR-13324 (Aerie Pharmaceuticals), PG324 ophthalmic solution (Aerie) and latanoprost.
AR-13324 is a Rho kinase inhibitor and norepinephrine transporter inhibitor. PG324 0.01% or 0.02% is a fixed-dose combination drug that comprises latanoprost 0.005% and AR-13324 0.01% or 0.02%.
The double-masked, parallel comparison study included 298 patients with open-angle glaucoma or ocular hypertension who were randomized to four treatment arms: PG324 ophthalmic solution 0.01% (74 patients), PG324 ophthalmic solution 0.02% (73 patients), latanoprost 0.005% (73 patients) and AR-13324 ophthalmic solution 0.02% (78 patients). Patients were dosed once daily for 28 days. Safety and efficacy were evaluated at 8, 15, 29 and 30 days. The primary efficacy metric was mean diurnal IOP at 29 days.
A total of 292 patients completed the study.
At 29 days, mean diurnal IOP decreased to 17.3 mm Hg in the PG324 0.01% group, 16.5 mm Hg in the PG324 0.02% group, 18.4 mm Hg in the latanoprost group and 19.1 mm Hg in the AR-13324 0.02% group.
For the primary efficacy metric of variable mean diurnal IOP at 29 days, PG324 0.02% met the criterion for statistical superiority to latanoprost and AR-13324 0.02%, with additional IOP lowering of 1.9 mm Hg and 2.6 mm Hg, respectively.
PG324 0.01% also reached that threshold, with an additional IOP reduction of 1.1 mm Hg and 1.8 mm Hg, respectively.
Conjunctival hyperemia was the most common adverse event, occurring in 41% of patients in the PG324 0.01% group, 40% of the PG324 0.02% group, 14% of the latanoprost group and 40% of the AR-13324 0.02% group. – by Matt Hasson
Disclosure: Lewis reports he is a consultant for Aerie Pharmaceuticals and several other ophthalmic pharmaceutical and medical device companies and a stockholder in Aerie Pharmaceuticals. See the full study for all other authors’ relevant financial disclosures.
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Lewis RA, et al. Br J Ophthalmol. 2015;doi:10.1136/bjophthalmol-2015-306778.
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