July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
A Phase 3 trial comparing omidenepag isopropyl 0.002% with latanoprost 0.005% in primary open-angle glaucoma and ocular hypertension: the AYAME study
Author Affiliations & Notes
  • Fenghe Lu
    Santen Inc., Emeryville, California, United States
  • Makoto Aihara
    Ophthalmology, University of Tokyo, Tokyo, Tokyo, Japan
  • Hisashi Kawata
    Santen Pharmaceutical Co., Ltd; , Osaka, Japan
  • Akihiro Iwata
    Santen Pharmaceutical Co., Ltd; , Osaka, Japan
  • Noriko Odani-Kawabata
    Santen Pharmaceutical Co., Ltd; , Osaka, Japan
  • Naveed K Shams
    Santen Inc., Emeryville, California, United States
    Santen Pharmaceutical Co., Ltd; , Osaka, Japan
  • Footnotes
    Commercial Relationships   Fenghe Lu, Santen Inc. (E); Makoto Aihara, Santen Pharmaceutical Co., Ltd. (F), Santen Pharmaceutical Co., Ltd. (R); Hisashi Kawata, Santen Pharmaceutical Co., Ltd. (E); Akihiro Iwata, Santen Pharmaceutical Co., Ltd. (E); Noriko Odani-Kawabata, Santen Pharmaceutical Co., Ltd. (E); Naveed Shams, Santen Inc. (E), Santen Pharmaceutical Co., Ltd. (E)
  • Footnotes
    Support  This study was sponsored by Santen
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1235. doi:
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      Fenghe Lu, Makoto Aihara, Hisashi Kawata, Akihiro Iwata, Noriko Odani-Kawabata, Naveed K Shams; A Phase 3 trial comparing omidenepag isopropyl 0.002% with latanoprost 0.005% in primary open-angle glaucoma and ocular hypertension: the AYAME study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1235.

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      © ARVO (1962-2015); The Authors (2016-present)

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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.

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