Purchase this article with an account.
Janet B Serle, Richard Alan Lewis, Casey Kopczynski, Theresa Heah; 3-month Interim Report of a Prospective 12-month Safety and Efficacy Study of Topical PG324 (Fixed Combination of Netarsudil 0.02% and Latanoprost 0.005%) Compared to the Individual Components in Subjects with Elevated Intraocular Pressure. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2462.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To assess the safety and efficacy of a fixed-dose combination of netarsudil 0.02% and latanoprost 0.005% (PG324) to its components in patients with elevated IOP.
A double-masked, active-controlled, parallel, randomized study in patients with open-angle glaucoma or ocular hypertension with unmedicated IOP (mmHg) >20 and <36 at 08:00 hours and >17 and <36 at 10:00 and 16:00 hours. Patients were dosed QD (PM) with PG324, netarsudil or latanoprost for 12 months. IOP was measured at 08:00, 10:00 and 16:00 hours at week 2, week 6 and month 3. Ocular and systemic side effects were collected, a 0 to 3 grading scale was used to assess hyperemia. Statistical analysis was performed using SAS Version 9.2 or higher.
Enrolled were 718 patients of which 85% (201/238), 82% (201/244) and 95% (223/236) completed three months of dosing in the PG324, netarsudil and latanoprost groups, respectively. Mean baseline IOP was similar across the groups and ranged from 22.4 to 24.8 mm Hg. Mean treated IOPs ranged from 14.8 to 16.0 mm Hg, 17.2 to 19.0 mm Hg and 16.7 to 17.8 mm Hg, respectively, with PG324 IOP reductions achieving statistical superiority to netarsudil and latanoprost at all 9 time points across the Week 2, Week 6 and Month 3 visits (p < 0.0001). Mean IOP reductions in the PG324 group were 1.8 to 3.0 mm Hg greater than in the netarsudil group, and 1.3 to 2.5 mm Hg greater than in the latanoprost group. At Month 3, 44% of PG324 subjects achieved mean diurnal IOPs of ≤15 mm Hg compared to 23% and 25% of netarsudil and latanoprost subjects, respectively (p < 0.0001). The most frequent adverse events were conjunctival hyperemia (53%, 41% and 14%, respectively) and conjunctival hemorrhage (11%, 14% and 0.4%, respectively), which were of mild severity and sporadic frequency for the majority of subjects. There were no drug-related serious or systemic adverse events.
The fixed dose combination of PG324 provided clinically and statistically significantly greater ocular hypotensive efficacy than its individual components, netarsudil and latanoprost. The safety profile of PG324 was similar to that of netarsudil alone. This fixed dose combination addresses the issues of patient compliance and enhanced ocular hypotensive efficacy.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
This PDF is available to Subscribers Only