July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
IOP lowering effect of omidenepag isopropyl in latanoprost non-/low-responder subjects with primary open-angle glaucoma or ocular hypertension: the FUJI study
Author Affiliations & Notes
  • Auli M Ropo
    Santen Oy, Helsinki, Finland
  • Makoto Aihara
    Ophthalmology, University of Tokyo, Tokyo, Japan
  • Fenghe Lu
    Santen Inc., Emeryville, California, United States
  • 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   Auli Ropo, Santen Oy (E); Makoto Aihara, Santen Pharmaceutical Co., Ltd. (F), Santen Pharmaceutical Co., Ltd. (R); Fenghe Lu, Santen Inc. (E); 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 Pharmaceutical Co., Ltd (E)
  • Footnotes
    Support  This study was sponsored by Santen.
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1233. doi:
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      Auli M Ropo, Makoto Aihara, Fenghe Lu, Hisashi Kawata, Akihiro Iwata, Noriko Odani-Kawabata, Naveed K Shams; IOP lowering effect of omidenepag isopropyl in latanoprost non-/low-responder subjects with primary open-angle glaucoma or ocular hypertension: the FUJI study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1233.

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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 study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of OMDI 0.002% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who were latanoprost non/low responders.

Methods : This was a multicenter open-label study (NCT02822742). Subjects underwent a 1–4-week washout period, followed by an 8-week run-in period with latanoprost 0.005% ophthalmic solution and a 4-week treatment period with OMDI 0.002% ophthalmic solution (once daily at night). Only subjects with an IOP reduction of ≤15% following latanoprost treatment from washout to the start of treatment (Day 1, baseline) were eligible for treatment with OMDI. The primary endpoint was the change from baseline (after the 8-week run-in period) in mean diurnal IOP to Week 4.

Results : Overall, 26 subjects (46.2% male, 65.4% ≥65 years) were included in the full analysis set and two prematurely discontinued from the study owing to lack of efficacy. The baseline mean diurnal IOP (± standard deviation) was 23.1±2.8 mmHg, which indicated that the subjects were latanoprost non/low responders. After switching from latanoprost to OMDI, the change from baseline in mean diurnal IOP at Week 4 was −2.99 mmHg (95% confidence interval −3.87, −2.11; P<0.0001). No serious adverse events (AEs) were reported. Six ocular AEs were reported in three patients. Ocular AEs of the anterior chamber cell (n=2), conjunctival hyperemia (n=2), and erythema of eyelid (n=1) were mild in severity, considered to be related to OMDI, and resolved during the study without intervention. One ocular AE (retinal hemorrhage) was not considered to be related to OMDI treatment.

Conclusions : In conclusion, OMDI 0.002% ophthalmic solution demonstrated a clinically significant IOP reduction in patients who were latanoprost non-/low-responders with few AEs. These data suggest that OMDI, with a novel mechanism of action, may provide an alternative treatment option for patients who do not respond well to latanoprost.
This study was 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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