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Makoto Aihara, Fenghe Lu, Hisashi Kawata, Akihiro Iwata, Noriko Odani-Kawabata, Naveed K Shams; Six-month efficacy and safety outcomes of a novel selective EP2 agonist omidenepag isopropyl: the RENGE study (Phase 3). Invest. Ophthalmol. Vis. Sci. 2018;59(9):1229.
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Omidenepag isopropyl (OMDI) is a selective EP2 receptor agonist, with a non-prostaglandin structure. This multicenter, open-label, Phase 3 study (NCT02822729) assessed the long-term safety and intraocular pressure (IOP)-lowering efficacy of OMDI 0.002% ophthalmic solution (one drop, once daily) in subjects with open-angle glaucoma (OAG), including normal tension glaucoma, or ocular hypertension (OHT). Here, the 6-month efficacy and safety data are presented.
Following a 1-4 weeks' washout period, subjects were treated with OMDI 0.002% once daily at 21:00 (±1 hour) for 6 months. Measurements of IOP were performed at 9:00, 13:00, and 17:00 at baseline and at Weeks 2, 4, 8, 12, and 26. Group 1 consisted of subjects with a baseline IOP of ≥16-<22 mmHg, and Group 2 comprised subjects with a baseline IOP of ≥22-<34 mmHg.
Overall, 48 subjects were enrolled in Group 1 and 37 subjects in Group 2. The mean diurnal IOP (±standard deviation) at baseline was 18.7±1.7 mmHg and 24.1±2.4 mmHg in the respective groups. Treatment with OMDI significantly reduced IOP in both groups at each visit (all P<0.0001, compared with baseline). Maximal mean diurnal IOP reduction was reached at Week 2. IOP reduction was sustained during the study (3.5 mmHg at Week 2 to 2.4 mmHg at Week 26 in Group 1; 5.9 mmHg at Week 2 to 4.9 mmHg at Week 26 in Group 2). One patient in Group 2 had a serious adverse event (AE), appendicitis, which was considered unrelated to OMDI; no serious AEs were reported in Group 1. The most frequently reported ocular AEs were conjunctival hyperemia (16/85, 18.8% in Groups 1 and 2 combined), followed by macular edema (ME) including cystoid ME (4/85, 4.7%). Iritis occurred in one patient (1/85, 1.2%). The ME cases were mild or moderate in severity and responsive to standard of care treatment and discontinuation of OMDI; all occurred in pseudophakic eyes. There were no AE reports of increased pigmentation of the iris, eyelid, and eyelashes in either group.
In conclusion, OMDI 0.002% ophthalmic solution demonstrated clinically significant IOP-lowering effects and had an acceptable safety profile in subjects with normal and elevated IOP. The IOP reduction was stable throughout the 26 weeks. These data suggest that OMDI provides a novel efficacious treatment option for subjects with OAG or OHT with once-daily dosing.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.
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