Abstract
Purpose :
Studies have shown that every mm Hg reduction in intraocular pressure (IOP) is associated with a decreased risk in the onset or progression of glaucoma. Latanoprostene bunod (LBN), a nitric oxide-donating prostaglandin F2α analogue, is in development for the reduction of IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). We evaluated the IOP-lowering effect of LBN ophthalmic solution 0.024% compared with timolol maleate ophthalmic solution 0.5% in a randomized controlled trial of subjects with OAG or OHT.
Methods :
This was a phase 3, multicenter, double-masked, parallel-group, non-inferiority study. Subjects ≥18 years of age with OAG or OHT were randomized (2:1) to LBN instilled qPM or timolol instilled BID for 3 months. Intraocular pressure was measured at 8am, 12pm, and 4pm at 2 weeks, 6 weeks, and 3 months post-randomization (9 time points; primary efficacy endpoint); differences between treatments in mean IOP were evaluated using an analysis of covariance. Secondary efficacy endpoints included the proportion of subjects with IOP ≤18 mm Hg and IOP reduction ≥25% at all 9 time points. Adverse events (AEs) were recorded throughout the study.
Results :
A total of 387 subjects (LBN 0.024%, n=259; timolol 0.5%, n=128) completed 3 months of double-masked treatment. LBN treatment led to significantly greater reductions in mean IOP compared to timolol (P≤0.025) at all but one time point (Week 2, 8 am). The mean reduction from baseline in mean diurnal IOP (average of IOP at 8am, 12pm, and 4pm) was significantly greater with LBN than with timolol at all study visits (-8.0 vs. -7.3, -8.4 vs. -7.5, and -8.4 vs. -7.3 mm Hg at week 2, 6, and month 3, respectively; P≤0.034). Of LBN- and timolol-treated subjects, 31.0% vs. 18.5% (P=0.007) had their IOP reduced ≥25% from baseline and 17.7% vs. 11.1%, (P=0.084) had their IOP reduced to ≤18 mm Hg at all 9 time points. Ocular treatment-emergent AEs were mild to moderate in severity and infrequent, though higher with LBN; all were mild to moderate in severity with one exception (conjunctival hyperemia in the LBN group).
Conclusions :
Results from this randomized controlled trial demonstrate that LBN 0.024% instilled qPM was effective at reducing IOP in patients with OAG or OHT over a 3 month period with a favorable safety profile.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.