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Kenneth Olander, Michelle A Sato, Marc A Abrams, Gary W Jerkins, Fenghe Lu, Phillip Dinh, NORIKO ODANI, Almira Chabi, Naveed Kamal Shams; A randomized Phase 2 trial assessing the safety and efficacy of omidenepag isopropyl 0.002% once and twice daily in subjects with primary open-angle glaucoma or ocular hypertension (Spectrum 6). Invest. Ophthalmol. Vis. Sci. 2020;61(7):4258.
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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).
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.
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.
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.
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