Abstract
Purpose :
Omidenepag, the active metabolite of omidenepag isopropyl (OMDI), is a selective non-prostaglandin, prostanoid EP2 receptor agonist. This study (NCT03858894) evaluated whether OMDI 0.002% with twice-daily (BID) dosing was superior to once-daily (QD) dosing in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Methods :
In this randomized, double-masked, parallel-group, multicenter, Phase 2 study, 98 qualified subjects were randomized 1:1 to receive either OMDI QD (8:00 PM and vehicle at 8:00 AM) or BID (8:00 PM and 8:00 AM) for 6 weeks (after a ≤4-week washout period depending on previous treatment class). Intraocular pressure (IOP) was measured at 8:00 AM, 12:00 PM, and 4:00 PM at baseline and Weeks 2 and 6. The primary efficacy endpoint was the IOP at each timepoint at Weeks 2 and 6. Adverse events (AEs), best-corrected visual acuity, slit lamp biomicroscopy, and ophthalmoscopy findings were recorded.
Results :
Baseline characteristics were balanced between the treatment arms. The baseline mean diurnal IOP±SD after the washout was 25.4±2.9 mmHg in the BID arm and 24.6±1.9 mmHg in the QD arm. At Weeks 2 and 6, OMDI BID and QD led to clinically significant and consistent IOP lowering from baseline. The differences in least squares mean±SE IOP between arms were not statistically significant (0.44±0.68 to 1.08±0.65 mmHg at Week 2 and 0.36±0.63 to 0.68±0.68 mmHg at Week 6; all timepoints: P>0.05). The least squares mean diurnal IOP±SE at Week 6 was 17.77±0.43 mmHg in the BID arm and 18.37±0.41 mmHg in the QD arm. AEs were more frequent in the BID arm (41.7%) compared with the QD arm (14.0%), including ocular AEs (BID: 37.5%; QD: 10.0%) and suspected adverse reactions (BID: 29.2%; QD: 6.0%; none serious). The most commonly reported AEs were conjunctival or ocular hyperemia (BID: 22.9%; QD: 2.0%). Five subjects discontinued the study drug prematurely, 4/5 owing to AEs. All discontinuations were in the BID treatment arm.
Conclusions :
IOP lowering in the BID arm was not superior to that of the QD arm. However, BID dosing was associated with a higher incidence of AEs, compared with QD dosing. Thus, OMDI QD dosing has a better overall efficacy/safety profile and is the preferred dosing frequency in the studied patient population.
Sponsored by Santen
This is a 2020 ARVO Annual Meeting abstract.