Abstract
Purpose :
Omidenepag isopropyl (OMDI) is a selective EP2 receptor agonist with a non-prostaglandin structure. The objective of this Phase 3, randomized, investigator-masked, active-controlled, parallel-group, multicenter study (NCT02623738) was to compare the efficacy and safety of OMDI 0.002% with latanoprost 0.005% (once daily [QD]) for 4 weeks in Japanese subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Methods :
After a washout period of 1–4 weeks, a baseline IOP of 22–34 mmHg at three timepoints (09:00, 13:00, and 17:00) in at least one eye was required for study entry. Eligible subjects were randomized (1:1) to OMDI or latanoprost for 4 weeks. Intraocular pressure (IOP) was measured at 9:00, 13:00, and 17:00 at Weeks 1, 2, and 4. The primary endpoint was the change from baseline in mean diurnal IOP at Week 4. The non-inferiority margin for OMDI versus latanoprost was 1.5 mmHg. Adverse events (AEs) were recorded.
Results :
In total,190 subjects were randomized. Among these, 189 had at least one post-baseline IOP measurement. At baseline, subjects receiving OMDI (n=94, 45.7% males, mean age [± SD]: 65.7±9.8 years) and latanoprost (n=95, 45.3% males, mean age [± SD]: 61.4±13.4 years) had a mean diurnal IOP (±SD) of 23.8±1.7 mmHg and 23.4±1.5 mmHg, respectively. At Week 4, the difference in the change from baseline in mean diurnal IOP for OMDI versus latanoprost was 0.63 mmHg in favor of latanoprost; the 95% confidence interval (0.01, 1.26) met the non-inferiority criterion for OMDI versus latanoprost. The most frequently reported ocular AEs (OMDI versus latanoprost) were conjunctival hyperemia (23/94 [24.5%] versus 10/96 [10.4%]), corneal thickening (11/94 [11.7%] versus 1/96 [1.0%]), and punctate keratitis (0/94 versus 7/96 [7.3%]). No serious AEs were observed in either group. Four patients discontinued following AEs: two receiving OMDI (both with adenoviral conjunctivitis) and two receiving latanoprost (one each with adenoviral conjunctivitis and palpitations).
Conclusions :
In conclusion, OMDI 0.002% was non-inferior to latanoprost 0.005% in reducing IOP in subjects with POAG or OHT and had an acceptable safety profile. Results suggest OMDI (administered QD) may offer an alternative treatment option to latanoprost with a novel mechanism of action.
Sponsored by Santen.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.