Study: Once daily omidenepag isopropyl therapy effective with improved safety
Omidenepag isopropyl (OMDI, Santen) q.d. dosing has a better overall efficacy and safety profile than b.i.d. dosing and is the preferred dosing frequency in the studied population, according to a study presented at AAO 2020 Virtual.
OMD, the active metabolite of OMDI, is a selective, non-prostaglandin EP2 receptor antagonist, which has been shown to lower IOP by increasing aqueous humor outflow via both the conventional and uveoscleral pathways. A randomized, multicenter US study compared the efficacy and safety of OMDI b.i.d. to q.d. dosing in subjects with primary open-angle glaucoma or ocular hypertension. After a ≤4-week washout, subjects received OMDI b.i.d. (n = 48) or q.d. (n = 50) for 6 weeks. IOP was measured at 8:00 AM, 12:00 PM, and 4:00 PM at baseline and the primary endpoint at Weeks 2 and 6.
Results demonstrated baseline mean diurnal IOP ± SD was 25.4 ± 2.9 mm Hg (b.i.d.) and 24.6 ± 1.9 mm Hg (q.d.). The Least Squares (LS) mean diurnal IOP ± SE at Week 6 was 17.77 ± 0.43 mm Hg (b.i.d.) and 18.37 ± 0.41 mm Hg (q.d.). LS mean ± SE IOP differences (b.i.d. minus q.d.) were not statistically significant (Week 2: 0.44 ± 0.68 to 1.08 ± 0.65 mm Hg; Week 6: 0.36 ± 0.63 to 0.68 ± 0.68 mm Hg). Overall, there were no significant between-arm differences in response rates at Week 2 or Week 6. Adverse events (AEs) occurred 3 times more frequently in the b.i.d. arm (41.7%; q.d.,14.0%). In total, 5 subjects discontinued OMDI prematurely, 4 because of AEs (all b.i.d.), including ocular hyperemia, iritis and nausea, conjunctival hyperemia, and ocular discomfort. OMDI QD was identified as the optimal dose frequency for the phase 3 clinical trial investigation, they reported.
Olander KW, et al. Randomized phase 2 trial assessing the safety and efficacy of Omidenepag isopropyl 0.002% once and twice daily. Presented at: AAO 2020 Virtual. [Session: PO0178].